1 year long contract!

We are looking for someone with a strong technical background in process and utility engineering to lead critical projects, ensuring compliance and operational excellence.

Key Responsibilities

• Lead project engineering and construction activities aligned with engineering workstreams, including trades during construction, project budgets, schedules, safety, and Amgen’s Commissioning and Qualification Process (CQP).
• Ensure new cGMP equipment is installed and maintained in a validated state, supporting equipment and facility design, compliance, and project management.
• Partner with maintenance, project management, engineering leads, and manufacturing teams to oversee equipment operation and reliability.
• Collaborate with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) to ensure regulatory compliance.
• Define strategies for quality systems verification and document practices in partnership with the process development and validation teams.

Preferred Qualifications / Skills

• Bachelor’s degree in engineering or another science-related field.
• Minimum of 2+ years of relevant work experience, with at least 1+ year in an operations/manufacturing environment.
• Experience in regulated environments (FDA, OSHA, EPA, etc.).
• Working knowledge of cGMP procedures and engineering practices in pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment.
• Proven expertise in implementing risk-based verification for major GMP process equipment/automation projects, including validation protocol development and execution.
• Familiarity with combination products/medical device quality systems verification.
• Knowledge of process equipment such as cell culture, fermentation, purification, filling, and packaging systems.
• Understanding of automation infrastructure, technologies, and project execution/verification for automation systems.
• Knowledge of Delta V, Rockwell, and Plant Information Systems (preferred).
• Experience in developing SOPs and delivering training.
• Ability to apply process improvement methodologies (e.g., PDCA, LEAN, Six Sigma) and basic statistical tools to improve business processes.