Sr Project Engineer

Career Category:
Engineering

Join Amgen’s mission of serving patients. In this role you will help make an impact on the lives of patients through research, manufacturing, and delivery of innovative medicines.

• Work with Facilities & Engineering, maintenance, process development, project management, engineering technical authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream.
• Collaborate closely with Quality Assurance (QA) for GMP and Safety compliance.
• Support projects in defining strategies for systems verification and work with the process development/validation team.
• Assist manufacturing activities associated with cGMP equipment and facilities.
• Be individually accountable for project deliverables.
• Identify, support, or lead engineering-based improvements or upgrades to equipment or facility systems.
• Develop business cases, design requirements, specifications, and support construction, startup, and validation of equipment.
• Develop and present project charters and strategies to leadership.
• Create accurate estimates, schedules, cost and schedule risk analysis, cash flow analysis, and benchmarking data.
• Lead team effectiveness by resolving issues, facilitating decisions, tracking action items, and handling escalations.
• Help identify critical quality parameters and process attributes for new equipment or facility modifications.
• Assist in developing and reviewing User Requirements Specifications (URS).
• Identify risks and develop mitigation countermeasures.
• Partner with the commissioning lead to develop a commissioning strategy based on URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES).
• Recommend, evaluate, and manage the performance of contract resources.
• Provide oversight for verification deliverables from outsourced/contract verification staff.
• Serve as liaison between cross‑functional teams during project planning, execution, and closeout.
• Ensure validation protocols are executed and documented per cGMP good documentation and safety compliant practices.
• Support manufacturing and QA with Performance Qualification (PQ) activities if applicable.

• Doctorate degree OR Master’s degree and 2 years of engineering and/or manufacturing experience
• Bachelor’s degree and 4 years of engineering and/or manufacturing experience
• Associate’s degree and 8 years of engineering and/or manufacturing experience
• High school diploma / GED and 10 years of engineering and/or manufacturing experience

• Bachelor’s degree in engineering or other science‑related field
• 8 or more years of relevant work experience in operations/manufacturing environment
• 5 or more years of engineering or construction experience in the pharmaceutical/biotechnology/regulated manufacturing industry executing projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support)
• Direct experience working within regulated environments (FDA, OSHA, EPA, etc.)
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
• Experience implementing risk‑based verification on major GMP process equipment / automation projects, including validation protocol development and execution
• Understanding and awareness of industry/regulatory trends for verification/validation
• Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging; facilities, utilities and equipment
• Strong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution/verification
• Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
• Demonstrated strong communication and technical writing skills
• Strengths in facilitation and collaboration / networking
• Experience in developing SOPs and delivering training
• Team player prepared to work in and embrace a team‑based culture that relies on collaboration for effective decision‑making
• Proven track record of applying process improvement methodologies to mature and…