Senior Project Engineer

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

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

• Preferred Fields of Study: Engineering (Chemical, Mechanical, Electrical, Industrial, Manufacturing, Automation, or related field)

• 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

• Experience supporting equipment qualification, facility qualification, utility qualification, and process validation activities

• Ability to identify, escalate, and resolve technical and execution risks before they impact project schedules

• Experience managing engineering contractors, vendors, and external service providers

• Strong stakeholder management skills with ability to influence decisions across multiple organizational levels

• Excellent written and verbal communication skills, including presentation of project status, risks, and technical recommendations to leadership teams

• Ability to develop integrated engineering execution plans and coordinate resource requirements across multiple projects

• Experience with project planning and execution tools such as MS Project, Smartsheet, Primavera, Planner, Visio, or equivalent systems

• Working knowledge of manufacturing automation, process control systems, utilities, and production equipment

• 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

PREFERRED QUALIFICATIONS:

• 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