Senior Validation Engineer
Thermo Fisher Scientific
South Carolina
19d ago

Job Description

Job Title : Senior Validation Engineer

Requisition ID : 67692BR

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe.

Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location / Division Specific Information

Our state-of-the-art 1400-acre API facility in Florence, SC!

How will you make an impact?

This position solves a wide range of difficult calibration and validation issues that impact multiple functions following cGMP regulations and standards and serves as technical subject matter expert (SME) in quality oversight of validation.

What will you do?

  • Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult calibration and validation issues.
  • Participate in the design and qualification stages of procuring new equipment, automation, cleaning validation and process monitoring.
  • Provide input into investigations involving equipment, automation, utility, cleaning validation, process monitoring and facility failures.
  • Administer a change management system for validated equipment, automation, utilities, cleaning validation, process monitoring and facilities.
  • Provide Quality oversight to ensure a compliant preventative maintenance, automation, cleaning validation and process monitoring programs.
  • Serve as the Quality representative on cross-functional and multi-site teams and represent the department on relevant project teams.
  • Education :

  • B.A. or B.S. degree (preferably in Life Science)
  • Experience :

  • F ive to seven years of experience in the pharmaceutical or biopharmaceutical industry
  • Experience in performing and reviewing temperature mapping studies (chambers, controlled rooms) and operation of associated testing equipment and probes ( e.g. Kaye Validator)
  • Knowledge, Skills, Abilities

  • Experience with validation (especially cleaning, automation and equipment validation), FDA experience and scientific knowledge of the industry.
  • Sound knowledge of cGMPs or equivalent regulations; ability to interpret and relate Quality standards for implementation and review.
  • Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
  • Flexibility in problem solving, providing direction and work hours to meet business objectives.
  • At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer.

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