Engineer - F&E Environmental & Contamination Control
Amgen
June 27, 2026
On-site
West Greenwich, RI
Operations
Engineer, F&E Environmental & Contamination Control
What You Will Do
- Report to Facilities & Engineering and serve as a technical deviation owner or functional area owner responsible for investigating and resolving equipment, utility, automation, facility, commissioning, qualification, and project-related quality events.
- Accountable for end-to-end management of assigned deviation records, ensuring investigations are technically sound, scientifically justified, inspection-ready, and completed per site procedures and regulatory expectations.
Responsibilities
- Translate complex engineering/equipment/automation/utility/project events into concise, technically accurate, inspection-ready documentation.
- Drive deviation investigations from initiation through closure; ensure compliance with site procedures and quality system requirements.
- Maintain accountability for record quality, data integrity, technical accuracy, and timely progression.
- Manage multiple investigations simultaneously.
- Develop and execute investigation strategies; perform field assessments/walkdowns/system reviews/Genba to gather evidence.
- Determine root cause and contributing factors; lead structured RCA sessions with cross-functional stakeholders.
- Evaluate impacts to validated systems, product quality, operational reliability, and compliance.
- Develop CAPAs (immediate and systemic), support effectiveness verification and monitoring.
- Partner with Manufacturing, QA/QC, Automation, Maintenance, Facilities, ETA, Process Development, Capital Projects, and Global Engineering.
- Create investigation narratives/assessments (chronology, causal analysis, risk, conclusions) and support impact assessments for equipment/utility/automation changes, C&Q, and capital projects.
- Serve as SME for regulatory inspections and internal audits; defend technical conclusions and risk-based decisions.
- Analyze deviation trends and use digital tools/data analytics/AI-enabled technologies to improve effectiveness.
Basic Qualifications
- HS diploma/GED + 8 years OR Associate’s + 6 years OR Bachelor’s + 2 years OR Master’s.
Preferred Qualifications
- BS/BA in Engineering, Life Sciences, Biotechnology, Chemistry, or related.
- 4+ years in regulated manufacturing (pharma/biotech/medical device).
- Experience with facilities & engineering systems, equipment troubleshooting, utility systems, automation (DeltaV/BAS/PI), C&Q, RCA, change control and quality systems.
- Strong technical writing and analytical problem-solving; ability to influence cross-functional teams; experience applying AI/analytics/digital tools.
Benefits (Total Rewards Plan; eligibility-based)
- Employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending); discretionary annual bonus/incentive; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; sponsorship not guaranteed.
What You Will Do
- Report to Facilities & Engineering and serve as a technical deviation owner or functional area owner responsible for investigating and resolving equipment, utility, automation, facility, commissioning, qualification, and project-related quality events.
- Accountable for end-to-end management of assigned deviation records, ensuring investigations are technically sound, scientifically justified, inspection-ready, and completed per site procedures and regulatory expectations.
Responsibilities
- Translate complex engineering/equipment/automation/utility/project events into concise, technically accurate, inspection-ready documentation.
- Drive deviation investigations from initiation through closure; ensure compliance with site procedures and quality system requirements.
- Maintain accountability for record quality, data integrity, technical accuracy, and timely progression.
- Manage multiple investigations simultaneously.
- Develop and execute investigation strategies; perform field assessments/walkdowns/system reviews/Genba to gather evidence.
- Determine root cause and contributing factors; lead structured RCA sessions with cross-functional stakeholders.
- Evaluate impacts to validated systems, product quality, operational reliability, and compliance.
- Develop CAPAs (immediate and systemic), support effectiveness verification and monitoring.
- Partner with Manufacturing, QA/QC, Automation, Maintenance, Facilities, ETA, Process Development, Capital Projects, and Global Engineering.
- Create investigation narratives/assessments (chronology, causal analysis, risk, conclusions) and support impact assessments for equipment/utility/automation changes, C&Q, and capital projects.
- Serve as SME for regulatory inspections and internal audits; defend technical conclusions and risk-based decisions.
- Analyze deviation trends and use digital tools/data analytics/AI-enabled technologies to improve effectiveness.
Basic Qualifications
- HS diploma/GED + 8 years OR Associate’s + 6 years OR Bachelor’s + 2 years OR Master’s.
Preferred Qualifications
- BS/BA in Engineering, Life Sciences, Biotechnology, Chemistry, or related.
- 4+ years in regulated manufacturing (pharma/biotech/medical device).
- Experience with facilities & engineering systems, equipment troubleshooting, utility systems, automation (DeltaV/BAS/PI), C&Q, RCA, change control and quality systems.
- Strong technical writing and analytical problem-solving; ability to influence cross-functional teams; experience applying AI/analytics/digital tools.
Benefits (Total Rewards Plan; eligibility-based)
- Employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending); discretionary annual bonus/incentive; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; sponsorship not guaranteed.