Engineering Project Manager

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.