Home › Companies › Hcfa Fa Us2 Oraclecloud Com CX › Senior Process Engineer
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
| Field | Value |
|---|---|
| Company | Hcfa Fa Us2 Oraclecloud Com CX |
| Title | Senior Process Engineer |
| Normalized title | - |
| Department / team | Process Engineering |
| Location | Brookhaven, NY, United States |
| Work model | - |
| Employment type | Full Time |
| Salary | $110,000–$115,000 / year |
| Status | active |
| ATS provider | Oracle Recruiting Cloud / Fusion HCM |
| Posted / first seen | 2026-05-29 / 2026-05-31 |
| Changed / last seen | 2026-06-06 / 2026-06-06 |
Related slices
| Page | What it contains | Open |
|---|---|---|
| Company jobs | Active postings from Hcfa Fa Us2 Oraclecloud Com CX. | 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 Brookhaven. | Open |
| Department jobs | Active postings in Process Engineering. | 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 | Hcfa Fa Us2 Oraclecloud Com CX |
| Source | 883d3ac1-899e-4648-b63e-68f77e57060e |
| ATS provider | Oracle 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 ID | abe95d718fb386bb43c18a44cfa1e718c827c77f |
| Org ID | 78a2aa0e-dc9e-4112-a79f-9ca9a23a5ca6 |
| Source ID | 883d3ac1-899e-4648-b63e-68f77e57060e |
| Board ID | 883d3ac1-899e-4648-b63e-68f77e57060e |
| Provider | oracle_hcm |
| Provider Job Key | 7475 |
| Title | Senior Process Engineer |
| Normalized Title | — |
| Status | active |
| Active | yes |
| Location Text | Brookhaven, NY, United States; Brookhaven, Brookhaven, NY, US |
| Department | Process Engineering |
| Team | — |
| Employment Type | full_time |
| Workplace Type | — |
| Remote Policy | — |
| Country | United States |
| Region | NY |
| City | Brookhaven |
| Salary Raw | 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. |
| Salary Min | 110,000 |
| Salary Max | 115,000 |
| Salary Currency | USD |
| Salary Period | year |
| Source URL | https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealCareers/job/7475 |
| Apply URL | https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealCareers/job/7475 |
| First Seen At | 2026-05-31 18:02:55Z |
| Last Seen At | 2026-06-06 11:05:55Z |
| Last Checked At | 2026-06-06 11:05:55Z |
| Last Changed At | 2026-06-06 11:05:55Z |
| Inactive At | — |
| Source Posted At | 2026-05-29 19:00:14Z |
| Source Updated At | — |
| Raw Payload Uri | s3://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 |
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