Senior Engineer, Environmental & Contamination Control

BioSpace; West Greenwich (RI); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Flexible work model

Time-off benefits

Job summary

Amgen is seeking a Sr. Engineer, F&E Environmental & Contamination Control to own deviations end‑to‑end, investigate equipment and facility events, and lead cross‑functional RCA sessions.

You will ensure QC/QA commitments, assess risk to validated systems, and drive CAPA execution with strong technical writing. Responsibilities include collaboration across Manufacturing, QA, Automation, and Facilities, while maintaining inspection readiness and compliance with QMS.

Qualifications

• BS/BA in Engineering, Life Sciences, Biotechnology, Chemistry, or related discipline.
• 5+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience with Facilities & Engineering systems, equipment troubleshooting, utility systems, automation, Commissioning & Qualification (C&Q).
• Strong technical writing and analytical problem-solving skills.
• Ability to influence and lead cross-functional teams without direct authority.

Responsibilities

• Own deviation investigations from initiation through closure with adherence to site procedures and quality system requirements.
• Lead structured RCA sessions involving cross-functional stakeholders and assess impact on validated systems and product quality.
• Develop technically robust corrective and preventive actions aligned with investigation outcomes.
• Collaborate with Manufacturing, Quality Assurance, Quality Control, Automation, Maintenance, Facilities, ETA, Process Development, Capital Projects, and Global Engineering.
• Develop investigation narratives and ensure documentation meets QMS requirements and inspection expectations.

Skills

Technical writing

Root Cause Analysis

Cross-functional collaboration

AI analytics

Automation systems

Education

BS/BA in Engineering or Life Sciences

Tools

DeltaV

BAS

PI

Job description

Amgen is seeking a Sr. Engineer, F&E Environmental & Contamination Control to own deviations end‑to‑end, investigate equipment and facility events, and lead cross‑functional RCA sessions.

You will ensure QC/QA commitments, assess risk to validated systems, and drive CAPA execution with strong technical writing. Responsibilities include collaboration across Manufacturing, QA, Automation, and Facilities, while maintaining inspection readiness and compliance with QMS.