Process Engineer III

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

When you join us at Thermo Fisher Scientific, you'll be part of a team that shares your passion for exploration and discovery! Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or improving their laboratories, we are here to support them.

How will you make an impact?

We are searching for a dedicated Process Engineer who will be responsible for leading projects aimed at designing, and documenting validation engineering activities as well as to develop and drive continuous improvement processes. The role also employs engineering and scientific rigor to drive process engineering problems to fundamental understanding.

What will you do?

• Lead multiple engineering projects and people aimed at excellence in safety, quality, process engineering and validation initiatives
• Develop project plans against business objectives, work multi-functionally to ensure results are clear and well-defined, to ensure project objectives and met and exceeded
• Mentor and coach junior engineers and technicians
• Follow all safety and current Good Manufacturing (cGMP) requirements within the plant
• Develop and implement Field Acceptance Testing (FAT) and Site Acceptance Testing (SAT) using User Requirement Specifications (URS)
• Lead validation engineering activities including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities
• Create, implement, and document validation activities within the plant-based system
• Use Design of Experiments (DOE) to optimize critical process parameters of manufacturing systems
• Proficient in technical writing including engineering protocols and reports as well as development and implementation of procedures
• Anticipate and address technical needs of customers and production via risk evaluation and mitigation
• Apply experience and expertise to identify and resolve root cause of equipment and production issues
• Self-motivated with good problem solving, communication, coordination, and mentoring skills
• Generation of specifications and documentation.
• Create and implement engineering test plans, validation and verification and engineering reports.
• Travel as required to perform job functions.

Minimum Qualifications:

• Minimum Education and Experience required: Bachelor's degree in Engineering, Statistics, Technical or related field and 5+ years experience or MS Degree and 3+ years experience.

Following skills desired:

• Experience with validation engineering in a regulated environment
• Standards knowledge including ISO9001 and ISO13485
• Ability to create detailed timelines (i.e. MS Project or similar), lead project teams, host team meetings and ensure project success
• Effective communication skills both written and verbal
• Positive, can-do attitude with ability to work independently and as a member of a multi-functional team
• Proficient in MS Office
• Ability to work in fast-paced results orientated environment
• Highly organized and self-motivated
• Development of test plans and test protocols.
• Project management including ability to accomplish and drive projects through others within the immediate team and within the multi-functional team.

Preferred Qualifications:

• Experience in the medical device, biopharmaceutical, or cell therapy industries preferred. Advanced or additional degree in a related field
• Statistical engineering skills (ANOVA, DOE, parametric, non-parametric tools, SPC, etc.) and software platforms (Minitab, JMP)
• Experience with qualification protocol generation and execution
• Experience with current Good Manufacturing Practices (cGMP) in pharmaceutical or medical device industries
• Six-Sigma knowledge/certification