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.

Location/Division Specific Information

Plainville, MA - Drug Substance

How will you make an impact?

By performing validation activities that include drafting, executing, reviewing, and approving quality documentation (User Requirement Specifications (URS), Commissioning protocols, IOQs, PQs, Re-qualifications, Periodic Reviews, Final Reports, Validation project plans, Investigations, and Risk Assessments) for clinical and commercial drug substance manufacturing of cell and gene therapy products.

What will you do?

• Identify any areas where non-compliance or non-harmonization is occurring.
• Analyze data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Provide technical direction to core teams and act as customer-facing lead for project teams.
• Evaluate current and new regulations, changes to existing regulations and regulatory trends; perform gap analysis to determine deficiencies and take appropriate actions.
• Participate in deviation investigations and supports change control assessments related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments.
• Leads and participates in multi-functional department teams for CQV efforts to meet established timeframe for project implementations that support business needs and meet global regulatory requirements.
• Support internal and external inspections for the subject matter
• Helps drive continuous quality system improvements
• Crafts and maintains CQV SOPs, Validation Master Plans and protocols Requalification program development and execution
• Builds and manages relationships with other VVS sites to develop and promote validation standard methodologies and ensures compliance with Thermo Fisher (PCG/VVS) SOP’s
• The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams.
• Perform other projects and duties as assigned by the Validation Engineering Manager/Director for the overall benefit of Thermo Fisher.

How will you get here?

Education

• BS in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field preferred

Experience

• 4+ Years Experience in Lean manufacturing experience preferred.
• Experience with SOP's.
• Experience within cGMP environment.

Knowledge, Skills, Abilities

• Analytical equipment validation experience is a plus (cell counters, blood gas analyzers, etc.)
• Computer Systems Validation (CSV) experience is a major pl
• Lean Manufacturing Certification preferred
• Kneat Experience preferred
• Six Sigma Experience preferred
• Familiarity with a variety of concepts, practices and procedures. Outstanding attention to detail and organizational skills.
• Knowledge of cGMPs and FDA/industry expectations. Works on projects of moderate to high complexity in regards to compliance of processes and product within facilities, equipment, manufacturing and support areas.
• Ability to work multi-functionally.
• Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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