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Senior Computer Systems Validation Engineer

Hcjy Fa Us2 Oraclecloud Com CX 1 · Trumbull, CT, United States; US-Trumbull 75, Trumbull, CT, US · On Site · Active · Oracle Recruiting Cloud / Fusion HCM

Job facts

Field	Value
Company	Hcjy Fa Us2 Oraclecloud Com CX 1
Title	Senior Computer Systems Validation Engineer
Normalized title	-
Department / team	Engineering
Location	Trumbull, CT, United States
Work model	On Site
Employment type	Full Time
Salary	-
Status	active
ATS provider	Oracle Recruiting Cloud / Fusion HCM
Posted / first seen	2026-04-20 / 2026-05-31
Changed / last seen	2026-05-31 / 2026-06-06

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Company jobs	Active postings from Hcjy Fa Us2 Oraclecloud Com CX 1.	Open
Company breakdowns	Role, location, ATS, and work model facets for this company.	Open
ATS provider jobs	Active postings observed through Oracle Recruiting Cloud / Fusion HCM.	Open
Provider filtered search	The same provider as a filtered job collection.	Open
City jobs	Active postings in Trumbull.	Open
Department jobs	Active postings in Engineering.	Open
Work model jobs	Active On Site postings.	Open
Lifecycle events	Open, update, close, and reopen events for this posting.	Open
Original posting	Canonical source or apply URL captured from the ATS.	Open

Linked records

Company	Hcjy Fa Us2 Oraclecloud Com CX 1
Source	063b269b-849a-4216-8d0d-8fc4f7efa6f5
ATS provider	Oracle Recruiting Cloud / Fusion HCM

Description

Description About CooperSurgical CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com . Work location: Trumbull, CT (on-site) Scope: The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI’s corporate CSV strategy to meet all applicable regulations. Job Summary: The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in regulated environments. This role is responsible for establishing and maintaining the corporate CSV framework, overseeing critical programs and complex enterprise systems, ensuring regulatory inspection readiness, and driving a risk‑based, inspection‑ready validation culture across the organization. Responsibilities Lead and guide Computer Systems Validation tasks and deliverables through enterprise and high‑risk programs throughout the systems life cycle. Propose streamlined approaches for CSV strategy and governance to meet compliance and usage of CSA. Ability to lead validation projects and/or validation tasks/phases of larger projects (including eQMS and Quality Systems). Drive inspection readiness and continuous improvement in CSV team. Train and mentor project team personnel (testers, business systems analysts) in computer systems lifecycle methodology. \Work closely with IT, manufacturing, quality control, quality assurance, infrastructure, and other teams to provide guidance on CSV. Provide guidance with functional/end user requirements, compliance, and system specifications, and ensure proper documentation is maintained to drive operational excellence. Provide test execution training and assist teams with discrepancy management. Support process owners for quality management systems and associated policies, procedures, and work instructions. Oversee requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements. Review and identify critical issues. Ensure compliance with internal and external computer system lifecycle policies and regulations. Communicate effectively with users to identify needs and evaluate alternative business solutions with project/QA Operations/Quality Management/Regulatory/IT Compliance. Ensure issues are identified, tracked, reported, and resolved in a timely manner. Perform other duties as assigned. Travel: This position may require 5-10% domestic and/or foreign travel. Qualifications Knowledge, Skills and Abilities: Experience in Computer Systems Validation, Software Quality Assurance, and Quality Management Systems. Knowledge of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies. Familiarity with computer systems used in support of GxP operations, and Computer System Validation documentation including CSV plans, requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports. Experience and knowledge of various QMSs, Agile PLM, MasterControl, Veeva, TrackWise, or equivalent system. Knowledge of regulatory requirements including CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP, ISO 13485, and ISO 14971. Ability to effectively engage and collaborate with cross-functional teams, including IT, Quality Assurance, Validation, and business project stakeholders. Knowledge of business enterprise functions and processes. Experienced in organizing meetings. Strong analytical and problem-solving skills with ability to identify issues, evaluate options, and implement effective solutions. Ability to adapt to a fast and dynamic environment and effectively engage with various functional and technical teams. Skilled in developing, following, and maintaining procedures and supporting documentation to ensure compliance and consistency. Strong written, verbal, and interpersonal communication skills (ability to communicate effectively with all stakeholders). Effective time management skills with proven adaptability to shifting priorities, resource changes, and scheduling adjustments. Ability to work independently and within teams (collaborative environment); self-motivated, self-directed, and detail oriented. Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat. Experience/knowledge of Agile PLM, MasterControl, IQVIA, or equivalent QMS system. Experience/knowledge of Waterfall, Agile, or Hybrid software development. Experience/knowledge of automated systems for following activities/functions is preferred: Enterprise Resource Planning (Oracle E Business Suite) Document management (SharePoint) Requirements and Testing (JIRA/Azure DevOps/HP ALM/HPQC) Change/Incident Management (ServiceNow) Project/Task Management (Smartsheet/Excel spreadsheets) Work Environment: Prolonged periods of sitting, especially in front of a computer. Potential exposure to different manufacturing environments, necessitating adherence to varying safety protocols. Experience: 7 +years of experience in assigned function's business process, engineering, and supporting systems for QA and Compliance departments. 5+ years of experience in Computer Systems Validation. Education: Bachelor of Science Degree, Computer Engineering, or relevant science field required, or equivalent combination of education and experience. #LI-KA1 Our Benefits: As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team. To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

Full job record

Job ID	1174de03145d4d05b8048464c23330e4675c2fd5
Org ID	fd5c005d-2102-408b-80a5-9404893f9b97
Source ID	063b269b-849a-4216-8d0d-8fc4f7efa6f5
Board ID	063b269b-849a-4216-8d0d-8fc4f7efa6f5
Provider	oracle_hcm
Provider Job Key	10864
Title	Senior Computer Systems Validation Engineer
Normalized Title	—
Status	active
Active	yes
Location Text	Trumbull, CT, United States; US-Trumbull 75, Trumbull, CT, US
Department	Engineering
Team	—
Employment Type	full_time
Workplace Type	on_site
Remote Policy	—
Country	United States
Region	CT
City	Trumbull
Salary Raw	Description About CooperSurgical CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com . Work location: Trumbull, CT (on-site) Scope: The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI’s corporate CSV strategy to meet all applicable regulations. Job Summary: The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in regulated environments. This role is responsible for establishing and maintaining the corporate CSV framework, overseeing critical programs and complex enterprise systems, ensuring regulatory inspection readiness, and driving a risk‑based, inspection‑ready validation culture across the organization. Responsibilities Lead and guide Computer Systems Validation tasks and deliverables through enterprise and high‑risk programs throughout the systems life cycle. Propose streamlined approaches for CSV strategy and governance to meet compliance and usage of CSA. Ability to lead validation projects and/or validation tasks/phases of larger projects (including eQMS and Quality Systems). Drive inspection readiness and continuous improvement in CSV team. Train and mentor project team personnel (testers, business systems analysts) in computer systems lifecycle methodology. \Work closely with IT, manufacturing, quality control, quality assurance, infrastructure, and other teams to provide guidance on CSV. Provide guidance with functional/end user requirements, compliance, and system specifications, and ensure proper documentation is maintained to drive operational excellence. Provide test execution training and assist teams with discrepancy management. Support process owners for quality management systems and associated policies, procedures, and work instructions. Oversee requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements. Review and identify critical issues. Ensure compliance with internal and external computer system lifecycle policies and regulations. Communicate effectively with users to identify needs and evaluate alternative business solutions with project/QA Operations/Quality Management/Regulatory/IT Compliance. Ensure issues are identified, tracked, reported, and resolved in a timely manner. Perform other duties as assigned. Travel: This position may require 5-10% domestic and/or foreign travel. Qualifications Knowledge, Skills and Abilities: Experience in Computer Systems Validation, Software Quality Assurance, and Quality Management Systems. Knowledge of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies. Familiarity with computer systems used in support of GxP operations, and Computer System Validation documentation including CSV plans, requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports. Experience and knowledge of various QMSs, Agile PLM, MasterControl, Veeva, TrackWise, or equivalent system. Knowledge of regulatory requirements including CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP, ISO 13485, and ISO 14971. Ability to effectively engage and collaborate with cross-functional teams, including IT, Quality Assurance, Validation, and business project stakeholders. Knowledge of business enterprise functions and processes. Experienced in organizing meetings. Strong analytical and problem-solving skills with ability to identify issues, evaluate options, and implement effective solutions. Ability to adapt to a fast and dynamic environment and effectively engage with various functional and technical teams. Skilled in developing, following, and maintaining procedures and supporting documentation to ensure compliance and consistency. Strong written, verbal, and interpersonal communication skills (ability to communicate effectively with all stakeholders). Effective time management skills with proven adaptability to shifting priorities, resource changes, and scheduling adjustments. Ability to work independently and within teams (collaborative environment); self-motivated, self-directed, and detail oriented. Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat. Experience/knowledge of Agile PLM, MasterControl, IQVIA, or equivalent QMS system. Experience/knowledge of Waterfall, Agile, or Hybrid software development. Experience/knowledge of automated systems for following activities/functions is preferred: Enterprise Resource Planning (Oracle E Business Suite) Document management (SharePoint) Requirements and Testing (JIRA/Azure DevOps/HP ALM/HPQC) Change/Incident Management (ServiceNow) Project/Task Management (Smartsheet/Excel spreadsheets) Work Environment: Prolonged periods of sitting, especially in front of a computer. Potential exposure to different manufacturing environments, necessitating adherence to varying safety protocols. Experience: 7 +years of experience in assigned function's business process, engineering, and supporting systems for QA and Compliance departments. 5+ years of experience in Computer Systems Validation. Education: Bachelor of Science Degree, Computer Engineering, or relevant science field required, or equivalent combination of education and experience. #LI-KA1 Our Benefits: As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team. To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
Salary Min	—
Salary Max	—
Salary Currency	—
Salary Period	—
Source URL	https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/10864
Apply URL	https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/10864
First Seen At	2026-05-31 17:56:25Z
Last Seen At	2026-06-06 18:54:57Z
Last Checked At	2026-06-06 18:54:57Z
Last Changed At	2026-05-31 17:56:25Z
Inactive At	—
Source Posted At	2026-04-20 13:49:09Z
Source Updated At	—
Raw Payload Uri	s3://job-postings-prod-raw-590183727216/raw/provider=oracle_hcm/board=hcjy.fa.us2.oraclecloud.com\|CX_1/date=2026-06-06/2026-06-06T18-54-41-336Z-a5965b54189b18264a41117402013b6b0f9a2ca665e465fc49b0f52e26911a85.json

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    "ExternalDescriptionStr": "<p class=\"elementtoproof\"><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\"><strong>About CooperSurgical</strong></span></span></p><p style=\"background-color: white; margin-bottom: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at&nbsp;</span></span><a href=\"http://www.coopersurgical.com\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">www.coopersurgical.com</span></span></a><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">.&nbsp;</span></span></p><p style=\"margin: 0in;\">&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><strong>Work location:</strong> Trumbull, CT (on-site)</span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Scope:</strong></span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\">The Senior Computer Systems Validation Engineer&nbsp;is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI’s corporate CSV strategy to meet all applicable regulations.</span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Job Summary:&nbsp;</strong></span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\">The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in regulated environments. This role is responsible for establishing and maintaining the corporate CSV framework, overseeing critical programs and complex enterprise systems, ensuring regulatory inspection readiness, and driving a risk‑based, inspection‑ready validation culture across the organization.</span></p>",
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    "ExternalQualificationsStr": "<p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Knowledge, Skills and Abilities:</strong></span></p><ul style=\"list-style-type: disc; padding-left: 72px;\"><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Experience in Computer Systems Validation, Software Quality Assurance, and Quality Management Systems.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Knowledge of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies.</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Familiarity with computer systems used in support of GxP operations, and Computer System Validation documentation including CSV plans, requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports.</span></span></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Experience and knowledge of various QMSs, Agile PLM, MasterControl, Veeva, TrackWise, or equivalent system.</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Knowledge of regulatory requirements including CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP, ISO 13485, and ISO 14971.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ability to effectively engage and collaborate with cross-functional teams, including IT, Quality Assurance, Validation, and business project stakeholders.</span></span></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Knowledge of business enterprise functions and processes. Experienced in organizing meetings.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Strong analytical and problem-solving skills with ability to identify issues, evaluate options, and implement effective solutions.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Ability to adapt to a fast and dynamic environment and effectively engage with various functional and technical teams.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Skilled in developing, following, and maintaining procedures and supporting documentation to ensure compliance and consistency.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Strong written, verbal, and interpersonal communication skills (ability to communicate effectively with all stakeholders).&nbsp;</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Effective time management skills with proven adaptability to shifting priorities, resource changes, and scheduling adjustments.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Ability to work independently and within teams (collaborative environment); self-motivated, self-directed, and detail oriented.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Experience/knowledge of Agile PLM, MasterControl, IQVIA, or equivalent QMS system.</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Experience/knowledge of Waterfall, Agile, or Hybrid software development.</span></span></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Experience/knowledge of automated systems for following activities/functions is preferred:</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Enterprise Resource Planning (Oracle E Business Suite)</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Document management (SharePoint)</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Requirements and Testing (JIRA/Azure DevOps/HP ALM/HPQC)</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Change/Incident Management (ServiceNow)</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Project/Task Management (Smartsheet/Excel spreadsheets)</span></span></li></ul><p>&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><strong>Work Environment:</strong></span></p><ul style=\"list-style-type: disc; padding-left: 72px;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Prolonged periods of sitting, especially in front of a computer.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Potential exposure to different manufacturing environments, necessitating adherence to varying safety protocols.</span></span></li></ul><p>&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><strong>Experience:</strong></span></p><ul style=\"list-style-type: disc; padding-left: 72px;\"><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">7 +years of experience in assigned function's business process, engineering, and supporting systems for QA and Compliance departments.</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">5+ years of experience in Computer Systems Validation.</span></span></li></ul><p style=\"margin-left: 0.25in;\">&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><strong>Education:</strong></span></p><ul style=\"padding-left: 72px;\"><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Bachelor of Science Degree, Computer Engineering, or relevant science field required, or equivalent combination of education and experience.</span></p></li></ul><p style=\"margin: 0in; vertical-align: baseline;\">&nbsp;</p><p style=\"margin: 0in; vertical-align: baseline;\">#LI-KA1</p><p style=\"margin: 0in; vertical-align: baseline;\">&nbsp;</p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><strong>Our Benefits:</strong></span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at&nbsp;</span><a href=\"https://www.coopersurgical.com/\" target=\"_blank\" title=\"https://www.coopersurgical.com/\"><span style=\"color: rgb(0, 135, 204); font-family: Arial, sans-serif;\">www.coopersurgical.com</span></a><span style=\"color: black; font-family: Arial, sans-serif;\">&nbsp;to learn more about CooperSurgical and the benefits of becoming a member of our team.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.</span></p>",
    "InternalQualificationsStr": "<p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Knowledge, Skills and Abilities:</strong></span></p><ul style=\"list-style-type: disc; padding-left: 72px;\"><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Experience in Computer Systems Validation, Software Quality Assurance, and Quality Management Systems.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Knowledge of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies.</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Familiarity with computer systems used in support of GxP operations, and Computer System Validation documentation including CSV plans, requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports.</span></span></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Experience and knowledge of various QMSs, Agile PLM, MasterControl, Veeva, TrackWise, or equivalent system.</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Knowledge of regulatory requirements including CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP, ISO 13485, and ISO 14971.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ability to effectively engage and collaborate with cross-functional teams, including IT, Quality Assurance, Validation, and business project stakeholders.</span></span></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Knowledge of business enterprise functions and processes. Experienced in organizing meetings.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Strong analytical and problem-solving skills with ability to identify issues, evaluate options, and implement effective solutions.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Ability to adapt to a fast and dynamic environment and effectively engage with various functional and technical teams.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Skilled in developing, following, and maintaining procedures and supporting documentation to ensure compliance and consistency.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Strong written, verbal, and interpersonal communication skills (ability to communicate effectively with all stakeholders).&nbsp;</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Effective time management skills with proven adaptability to shifting priorities, resource changes, and scheduling adjustments.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Ability to work independently and within teams (collaborative environment); self-motivated, self-directed, and detail oriented.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat.</span></p></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Experience/knowledge of Agile PLM, MasterControl, IQVIA, or equivalent QMS system.</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Experience/knowledge of Waterfall, Agile, or Hybrid software development.</span></span></li><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Experience/knowledge of automated systems for following activities/functions is preferred:</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Enterprise Resource Planning (Oracle E Business Suite)</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Document management (SharePoint)</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Requirements and Testing (JIRA/Azure DevOps/HP ALM/HPQC)</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Change/Incident Management (ServiceNow)</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Project/Task Management (Smartsheet/Excel spreadsheets)</span></span></li></ul><p>&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><strong>Work Environment:</strong></span></p><ul style=\"list-style-type: disc; padding-left: 72px;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Prolonged periods of sitting, especially in front of a computer.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Potential exposure to different manufacturing environments, necessitating adherence to varying safety protocols.</span></span></li></ul><p>&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><strong>Experience:</strong></span></p><ul style=\"list-style-type: disc; padding-left: 72px;\"><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">7 +years of experience in assigned function's business process, engineering, and supporting systems for QA and Compliance departments.</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">5+ years of experience in Computer Systems Validation.</span></span></li></ul><p style=\"margin-left: 0.25in;\">&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><strong>Education:</strong></span></p><ul style=\"padding-left: 72px;\"><li><p style=\"margin-bottom: 0in; margin-right: 0in; margin-top: 0in; vertical-align: baseline;\"><span style=\"font-family: Arial, sans-serif;\">Bachelor of Science Degree, Computer Engineering, or relevant science field required, or equivalent combination of education and experience.</span></p></li></ul><p style=\"margin: 0in; vertical-align: baseline;\">&nbsp;</p><p style=\"margin: 0in; vertical-align: baseline;\">#LI-KA1</p><p style=\"margin: 0in; vertical-align: baseline;\">&nbsp;</p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><strong>Our Benefits:</strong></span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at&nbsp;</span><a href=\"https://www.coopersurgical.com/\" target=\"_blank\" title=\"https://www.coopersurgical.com/\"><span style=\"color: rgb(0, 135, 204); font-family: Arial, sans-serif;\">www.coopersurgical.com</span></a><span style=\"color: black; font-family: Arial, sans-serif;\">&nbsp;to learn more about CooperSurgical and the benefits of becoming a member of our team.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.</span></p>",
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    "ExternalResponsibilitiesStr": "<ul style=\"padding-left: 72px;\"><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 31.35pt; margin-top: 0in;\"><span style=\"font-size: 10pt;\">Lead and guide Computer Systems Validation tasks and deliverables through enterprise and high‑risk programs throughout the systems life cycle.</span></p></li><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 31.35pt; margin-top: 0in;\"><span style=\"font-size: 10pt;\">Propose streamlined approaches for CSV strategy and governance to meet compliance and usage of CSA.</span></p></li><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 46.05pt; margin-top: 0in;\"><span style=\"font-size: 10pt;\">Ability to lead validation projects and/or validation tasks/phases of larger projects (including eQMS and Quality Systems).</span></p></li><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 31.35pt; margin-top: 0in;\"><span style=\"font-size: 10pt;\">Drive inspection readiness and continuous improvement in CSV team.</span></p></li><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 20.25pt; margin-top: 0in;\"><span style=\"font-size: 10pt;\">Train and mentor project team personnel (testers, business systems analysts) in computer systems lifecycle methodology.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">\\Work closely with IT, manufacturing, quality control, quality assurance, infrastructure, and other teams to provide guidance on CSV.</span></p></li><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 18.3pt; margin-top: 0.1pt;\"><span style=\"font-size: 10pt;\">Provide guidance with functional/end user requirements, compliance, and system specifications, and ensure proper documentation is maintained to drive operational excellence.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Provide test execution training and assist teams with discrepancy management.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Support process owners for quality management systems and associated policies, procedures, and work instructions.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Oversee requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements. Review and identify critical issues.&nbsp;</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Ensure compliance with internal and external computer system lifecycle policies and regulations.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Communicate effectively with users to identify needs and evaluate alternative business solutions with project/QA Operations/Quality Management/Regulatory/IT Compliance.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Ensure issues are identified, tracked, reported, and resolved in a timely manner.</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Perform other duties as assigned.</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Travel: </strong>This position may require 5-10% domestic and/or foreign travel.&nbsp;</span></p>",
    "InternalResponsibilitiesStr": "<ul style=\"padding-left: 72px;\"><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 31.35pt; margin-top: 0in;\"><span style=\"font-size: 10pt;\">Lead and guide Computer Systems Validation tasks and deliverables through enterprise and high‑risk programs throughout the systems life cycle.</span></p></li><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 31.35pt; margin-top: 0in;\"><span style=\"font-size: 10pt;\">Propose streamlined approaches for CSV strategy and governance to meet compliance and usage of CSA.</span></p></li><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 46.05pt; margin-top: 0in;\"><span style=\"font-size: 10pt;\">Ability to lead validation projects and/or validation tasks/phases of larger projects (including eQMS and Quality Systems).</span></p></li><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 31.35pt; margin-top: 0in;\"><span style=\"font-size: 10pt;\">Drive inspection readiness and continuous improvement in CSV team.</span></p></li><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 20.25pt; margin-top: 0in;\"><span style=\"font-size: 10pt;\">Train and mentor project team personnel (testers, business systems analysts) in computer systems lifecycle methodology.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">\\Work closely with IT, manufacturing, quality control, quality assurance, infrastructure, and other teams to provide guidance on CSV.</span></p></li><li><p class=\"TableParagraph\" style=\"margin-bottom: 0.0001pt; margin-right: 18.3pt; margin-top: 0.1pt;\"><span style=\"font-size: 10pt;\">Provide guidance with functional/end user requirements, compliance, and system specifications, and ensure proper documentation is maintained to drive operational excellence.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Provide test execution training and assist teams with discrepancy management.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Support process owners for quality management systems and associated policies, procedures, and work instructions.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Oversee requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements. Review and identify critical issues.&nbsp;</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Ensure compliance with internal and external computer system lifecycle policies and regulations.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Communicate effectively with users to identify needs and evaluate alternative business solutions with project/QA Operations/Quality Management/Regulatory/IT Compliance.</span></p></li><li><p class=\"TableParagraph\"><span style=\"font-size: 10pt;\">Ensure issues are identified, tracked, reported, and resolved in a timely manner.</span></p></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Perform other duties as assigned.</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Travel: </strong>This position may require 5-10% domestic and/or foreign travel.&nbsp;</span></p>",
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    "ShortDescriptionStr": "About CooperSurgical\n\nCooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. \n\nWork location: Trumbull, CT (on-site)",
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