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Senior Process Engineer

Hcfa Fa Us2 Oraclecloud Com CX · Brookhaven, NY, United States; Brookhaven, Brookhaven, NY, US · Active · $110,000–$115,000 / year · Oracle Recruiting Cloud / Fusion HCM

Job facts

FieldValue
CompanyHcfa Fa Us2 Oraclecloud Com CX
TitleSenior Process Engineer
Normalized title-
Department / teamProcess Engineering
LocationBrookhaven, NY, United States
Work model-
Employment typeFull Time
Salary$110,000–$115,000 / year
Statusactive
ATS providerOracle Recruiting Cloud / Fusion HCM
Posted / first seen2026-05-29 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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ATS provider jobsActive postings observed through Oracle Recruiting Cloud / Fusion HCM.Open
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City jobsActive postings in Brookhaven.Open
Department jobsActive postings in Process Engineering.Open
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Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

CompanyHcfa Fa Us2 Oraclecloud Com CX
Source883d3ac1-899e-4648-b63e-68f77e57060e
ATS providerOracle Recruiting Cloud / Fusion HCM

Description

Description Description: The Senior Process Engineer in sterile manufacturing will ensure the compliant, efficient, and safe transfer of new products, implementing manufacturing processes from concept to launch, including scaling up and aseptic process simulation. The position will lead continuous improvement initiatives and support process discrepancies. The role serves as Subject Matter Expert (SME) for providing technical expertise for sterile/aseptic, filling and packaging technologies, formulation, Lyophilization, depyrogenation and root cause analysis. Essential Functions: Develop, author, and execute protocols to ensure compliance with FDA and cGMP requirements, including process validation, cleaning validation, and automated system and control qualification. Monitor, interpret, and analyze manufacturing data to support the full process lifecycle, identifying opportunities for improvement and facilitating investigations to resolve process deviations and anomalies. Develop and manage technical plans, project scopes, design suitability studies, and implementation schedules to establish manufacturing process capability and support the introduction of new or reformulated products. Conduct feasibility assessments, risk analyses, budgeting, and project execution in alignment with business objectives. Collaborate closely with R&D and Manufacturing teams to transition processes from development to scale‑up and full commercial production. Evaluate and implement new technologies to strengthen and expand manufacturing capabilities. Provide real‑time troubleshooting for complex manufacturing equipment failures and process deviations, ensuring prompt resolution to maintain operational continuity. Lead personnel training, develop manufacturing instructions, and support the start‑up of new processes and equipment. Monitor key performance indicators—including quality, yield, throughput, cycle time, and critical process parameters—to drive improvements and ensure compliance with cGMP, safety, and environmental requirements. Collaborate with vendors and suppliers to define system requirements and validate functional specifications for sterilization, decontamination, and environmental control systems. Serve as a Subject Matter Expert (SME) by providing advanced technical expertise across key manufacturing processes, including chemical and biological formulation, filling, packaging, and contamination‑control operations. Develop and revise SOPs, ensuring alignment with regulatory and operational requirements. Lead and manage change controls and conduct impact assessments to support compliant process modifications. Support and lead investigations to determine root causes, perform data analysis, and drive effective CAPA implementation. Contribute to the creation and revision of process documentation and batch records to ensure accuracy, compliance, and continuous improvement. Additional Responsibilities: Verify and develop P&ID, engineering layout, engineering drawings and engineering documents. Employ key project management principles including establishing and tracking timelines, identifying and mitigating risks, and communicating across teams at all levels. Qualifications Education: Bachelors Degree (BA/BS) Engineering, manufacturing or related field - Required Master Degree (MS/MA) Engineering, manufacturing or related field - Preferred Experience: 5 years or more in Experience in engineering roles within a GMP manufacturing environment/Life science with sterile/aseptic facility. Specialized Knowledge: Strong understanding of cGMP, FDA regulations, and other relevant standards. Proven project management and leadership skills. Exceptional problem-solving and decision-making abilities. Strong communication and interpersonal skills to facilitate collaboration across teams. Proficiency in relevant engineering software and tools. Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test. The base salary for this position ranges from $110,000 to $115,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities. Company Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [email protected] . Requests will be handled confidentially and in accordance with applicable laws.

Full job record

Job IDabe95d718fb386bb43c18a44cfa1e718c827c77f
Org ID78a2aa0e-dc9e-4112-a79f-9ca9a23a5ca6
Source ID883d3ac1-899e-4648-b63e-68f77e57060e
Board ID883d3ac1-899e-4648-b63e-68f77e57060e
Provideroracle_hcm
Provider Job Key7475
TitleSenior Process Engineer
Normalized Title
Statusactive
Activeyes
Location TextBrookhaven, NY, United States; Brookhaven, Brookhaven, NY, US
DepartmentProcess Engineering
Team
Employment Typefull_time
Workplace Type
Remote Policy
CountryUnited States
RegionNY
CityBrookhaven
Salary RawDescription Description: The Senior Process Engineer in sterile manufacturing will ensure the compliant, efficient, and safe transfer of new products, implementing manufacturing processes from concept to launch, including scaling up and aseptic process simulation. The position will lead continuous improvement initiatives and support process discrepancies. The role serves as Subject Matter Expert (SME) for providing technical expertise for sterile/aseptic, filling and packaging technologies, formulation, Lyophilization, depyrogenation and root cause analysis. Essential Functions: Develop, author, and execute protocols to ensure compliance with FDA and cGMP requirements, including process validation, cleaning validation, and automated system and control qualification. Monitor, interpret, and analyze manufacturing data to support the full process lifecycle, identifying opportunities for improvement and facilitating investigations to resolve process deviations and anomalies. Develop and manage technical plans, project scopes, design suitability studies, and implementation schedules to establish manufacturing process capability and support the introduction of new or reformulated products. Conduct feasibility assessments, risk analyses, budgeting, and project execution in alignment with business objectives. Collaborate closely with R&D and Manufacturing teams to transition processes from development to scale‑up and full commercial production. Evaluate and implement new technologies to strengthen and expand manufacturing capabilities. Provide real‑time troubleshooting for complex manufacturing equipment failures and process deviations, ensuring prompt resolution to maintain operational continuity. Lead personnel training, develop manufacturing instructions, and support the start‑up of new processes and equipment. Monitor key performance indicators—including quality, yield, throughput, cycle time, and critical process parameters—to drive improvements and ensure compliance with cGMP, safety, and environmental requirements. Collaborate with vendors and suppliers to define system requirements and validate functional specifications for sterilization, decontamination, and environmental control systems. Serve as a Subject Matter Expert (SME) by providing advanced technical expertise across key manufacturing processes, including chemical and biological formulation, filling, packaging, and contamination‑control operations. Develop and revise SOPs, ensuring alignment with regulatory and operational requirements. Lead and manage change controls and conduct impact assessments to support compliant process modifications. Support and lead investigations to determine root causes, perform data analysis, and drive effective CAPA implementation. Contribute to the creation and revision of process documentation and batch records to ensure accuracy, compliance, and continuous improvement. Additional Responsibilities: Verify and develop P&ID, engineering layout, engineering drawings and engineering documents. Employ key project management principles including establishing and tracking timelines, identifying and mitigating risks, and communicating across teams at all levels. Qualifications Education: Bachelors Degree (BA/BS) Engineering, manufacturing or related field - Required Master Degree (MS/MA) Engineering, manufacturing or related field - Preferred Experience: 5 years or more in Experience in engineering roles within a GMP manufacturing environment/Life science with sterile/aseptic facility. Specialized Knowledge: Strong understanding of cGMP, FDA regulations, and other relevant standards. Proven project management and leadership skills. Exceptional problem-solving and decision-making abilities. Strong communication and interpersonal skills to facilitate collaboration across teams. Proficiency in relevant engineering software and tools. Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test. The base salary for this position ranges from $110,000 to $115,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities. Company Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [email protected] . Requests will be handled confidentially and in accordance with applicable laws.
Salary Min110,000
Salary Max115,000
Salary CurrencyUSD
Salary Periodyear
Source URLhttps://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealCareers/job/7475
Apply URLhttps://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealCareers/job/7475
First Seen At2026-05-31 18:02:55Z
Last Seen At2026-06-06 11:05:55Z
Last Checked At2026-06-06 11:05:55Z
Last Changed At2026-06-06 11:05:55Z
Inactive At
Source Posted At2026-05-29 19:00:14Z
Source Updated At
Raw Payload Uris3://job-postings-prod-raw-590183727216/raw/provider=oracle_hcm/board=hcfa.fa.us2.oraclecloud.com|CX/date=2026-06-06/2026-06-06T11-05-48-271Z-934f12f1f07d97c59fa37e30facb81c1cc9628f28bcd85278ee7fe6e0901eb98.json
Event Fields
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Parsed Structured
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