Sr. Engineer - F&E Environmental & Contamination Control
Amgen
August 12, 2026
Remote friendly (West Greenwich, RI)
United States
Operations
Sr. Engineer, F&E Environmental & Contamination Control
What You Will Do
- Report to Facilities & Engineering and serve as a technical deviation owner/functional area owner responsible for investigating and resolving equipment, utility, automation, facility, commissioning, qualification, and project-related quality events.
- Manage assigned deviation records end-to-end, ensuring investigations are technically sound, scientifically justified, inspection-ready, and completed per site procedures and regulatory expectations.
Responsibilities
- Demonstrated technical writing to create concise, technically accurate, inspection-ready documentation.
- Independently drive deviation investigations from initiation to closure; ensure compliance with site procedures and quality system requirements.
- Maintain accountability for record quality, data integrity, technical accuracy, and timely progression of deviations.
- Prioritize and manage multiple investigations in a dynamic manufacturing environment.
- Develop and execute investigation strategies; perform field assessments, equipment walkdowns, system reviews, and Genba.
- Determine root cause/contributing factors; lead structured RCA with cross-functional stakeholders.
- Develop and execute CAPAs; ensure systemic and immediate cause coverage; support effectiveness verification and monitoring.
- Partner cross-functionally (Manufacturing, QA/QC, Automation, Maintenance, Facilities, ETAs, Process Development, Capital Projects, Global Engineering).
- Create investigation narratives and technical assessments; support impact assessments for modifications, utility/automation updates, C&Q, and capital projects.
- Serve as SME during regulatory inspections/internal audits; defend technical conclusions and risk-based decisions.
- Analyze deviation trends and use digital tools/analytics/AI-enabled technologies to improve effectiveness and efficiency.
What We Expect Of You
Basic Qualifications:
- High school/GED + 10 years relevant experience; OR Associate’s + 8 years; OR Bachelor’s + 4 years; OR Master’s + 2 years; OR Doctorate.
Preferred Qualifications/Skills:
- BS/BA in Engineering, Life Sciences, Biotechnology, Chemistry, or related.
- 5+ years in pharmaceutical/biotech/medical device or other regulated manufacturing.
- Experience with facilities & engineering systems, troubleshooting, utility systems, automation (DeltaV, BAS, PI), C&Q, RCA methodologies, change control/quality systems.
- Strong technical writing and analytical problem-solving.
- Ability to influence/lead cross-functional teams without direct authority.
- Experience applying AI/analytics/digital tools to investigations and continuous improvement.
Benefits (explicitly listed)
- Comprehensive benefits package: retirement & savings plan (company contributions), medical/dental/vision, life & disability insurance, flexible spending accounts.
- Discretionary annual bonus (or sales incentive for field sales).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com.
- No application deadline; applications accepted until a sufficient number are received or a candidate is selected.
- Sponsorship for this role is not guaranteed.
What You Will Do
- Report to Facilities & Engineering and serve as a technical deviation owner/functional area owner responsible for investigating and resolving equipment, utility, automation, facility, commissioning, qualification, and project-related quality events.
- Manage assigned deviation records end-to-end, ensuring investigations are technically sound, scientifically justified, inspection-ready, and completed per site procedures and regulatory expectations.
Responsibilities
- Demonstrated technical writing to create concise, technically accurate, inspection-ready documentation.
- Independently drive deviation investigations from initiation to closure; ensure compliance with site procedures and quality system requirements.
- Maintain accountability for record quality, data integrity, technical accuracy, and timely progression of deviations.
- Prioritize and manage multiple investigations in a dynamic manufacturing environment.
- Develop and execute investigation strategies; perform field assessments, equipment walkdowns, system reviews, and Genba.
- Determine root cause/contributing factors; lead structured RCA with cross-functional stakeholders.
- Develop and execute CAPAs; ensure systemic and immediate cause coverage; support effectiveness verification and monitoring.
- Partner cross-functionally (Manufacturing, QA/QC, Automation, Maintenance, Facilities, ETAs, Process Development, Capital Projects, Global Engineering).
- Create investigation narratives and technical assessments; support impact assessments for modifications, utility/automation updates, C&Q, and capital projects.
- Serve as SME during regulatory inspections/internal audits; defend technical conclusions and risk-based decisions.
- Analyze deviation trends and use digital tools/analytics/AI-enabled technologies to improve effectiveness and efficiency.
What We Expect Of You
Basic Qualifications:
- High school/GED + 10 years relevant experience; OR Associate’s + 8 years; OR Bachelor’s + 4 years; OR Master’s + 2 years; OR Doctorate.
Preferred Qualifications/Skills:
- BS/BA in Engineering, Life Sciences, Biotechnology, Chemistry, or related.
- 5+ years in pharmaceutical/biotech/medical device or other regulated manufacturing.
- Experience with facilities & engineering systems, troubleshooting, utility systems, automation (DeltaV, BAS, PI), C&Q, RCA methodologies, change control/quality systems.
- Strong technical writing and analytical problem-solving.
- Ability to influence/lead cross-functional teams without direct authority.
- Experience applying AI/analytics/digital tools to investigations and continuous improvement.
Benefits (explicitly listed)
- Comprehensive benefits package: retirement & savings plan (company contributions), medical/dental/vision, life & disability insurance, flexible spending accounts.
- Discretionary annual bonus (or sales incentive for field sales).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com.
- No application deadline; applications accepted until a sufficient number are received or a candidate is selected.
- Sponsorship for this role is not guaranteed.