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Thermo Fisher Scientific Validation Engineer II in Plainville, Massachusetts

  • 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.

  • 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

How will you get here?

Education

  • BS preferred in chemical/biomedical/manufacturing engineering, molecular biology/virology or a related field with 0-3+ years experience

Experience

  • Lean manufacturing experience preferred.

  • Experience with SOP's.

  • Experience within cGMP environment.

Knowledge, Skills, Abilities

  • Knowledge of Lean Manufacturing Certification preferred

  • Knowledge of Six Sigma Experience

  • 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.

  • Self-starter, mature, independent, and diligent

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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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