Senior Project Engineer

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 Bachelors 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