Senior Project Engineer

Thermo Fisher Scientific • Middletown, VA

27d • Onsite

About The Position

As an Engineering Execution Lead within Manufacturing Engineering at Thermo Fisher Scientific, you will play a critical role in delivering complex manufacturing modernization, capital, and operational readiness projects that support our mission of making the world healthier, cleaner, and safer. This role serves as the primary engineering integration point between Engineering, Validation, Quality, Operations, Facilities, Supply Chain, and external partners to ensure projects are designed, executed, qualified, and transitioned successfully into routine operations. The Engineering Execution Lead is responsible for driving engineering workstreams from concept through implementation, including scope development, design coordination, risk management, engineering documentation, equipment modifications, facility upgrades, utility changes, and qualification readiness. This role focuses on execution leadership, ensuring engineering deliverables are completed on time, dependencies are actively managed, risks are escalated early, and project commitments are met. Working across multiple concurrent projects, you will coordinate internal and external engineering resources, establish clear priorities, facilitate technical decision-making, and maintain alignment between engineering activities and overall project schedules. You will partner closely with Validation and Quality teams to ensure engineering packages are inspection-ready, support qualification execution, and enable successful product and process implementation in regulated manufacturing environments. Success in this role requires strong technical judgment, exceptional organizational skills, proactive communication, and the ability to influence cross-functional teams without direct authority.

Requirements

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical, biotechnology, medical device, diagnostics, or other regulated manufacturing environments
• Demonstrated experience leading engineering execution for capital projects, manufacturing modernization initiatives, facility upgrades, equipment installations, or process improvement programs
• Strong project and program management skills with proven ability to manage multiple concurrent engineering workstreams and competing priorities
• Experience coordinating engineering activities across Quality, Validation, Operations, Facilities, Supply Chain, Procurement, and external contractors
• Experience developing and managing engineering deliverables including: User Requirement Specifications (URS) Functional Requirement Specifications (FRS) Design Reviews Risk Assessments Engineering Studies Commissioning and Qualification Support Documentation
• Understanding of cGMP requirements, validation lifecycle principles, and change control processes
• Ability to work in manufacturing environments, including cleanrooms and controlled areas, as required
• Available for occasional travel and off-hours support during critical implementation, startup, or qualification activities

Nice To Haves

• PMP, CAPM, or equivalent project management certification
• Experience leading site modernization, technology transfer, facility expansion, or manufacturing transformation programs
• Experience supporting FDA, ISO, customer, or regulatory inspections
• Demonstrated ability to lead engineering execution through ambiguity and changing business priorities
• Experience building execution plans, resource forecasts, and engineering readiness assessments for complex manufacturing programs

Responsibilities

• Driving engineering workstreams from concept through implementation, including scope development, design coordination, risk management, engineering documentation, equipment modifications, facility upgrades, utility changes, and qualification readiness.
• Coordinating internal and external engineering resources, establishing clear priorities, facilitating technical decision-making, and maintaining alignment between engineering activities and overall project schedules.
• Partnering closely with Validation and Quality teams to ensure engineering packages are inspection-ready, support qualification execution, and enable successful product and process implementation in regulated manufacturing environments.
• Identifying, escalating, and resolving technical and execution risks before they impact project schedules.
• Managing engineering contractors, vendors, and external service providers.
• Developing integrated engineering execution plans and coordinating resource requirements across multiple projects.
• Supporting equipment qualification, facility qualification, utility qualification, and process validation activities.
• Adhering to all Good Manufacturing Practices (GMP) Safety Standards.

Benefits

• Thermo Fisher Scientific is an Equal Opportunity Employer.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior