Validation Engineer III

3 weeks ago


Allentown, Pennsylvania, United States Thermo Fisher Scientific Full time

Job Summary

Thermo Fisher Scientific is seeking a highly skilled Validation Engineer III to join our team. As a Validation Engineer III, you will be responsible for providing validation support for computer systems, equipment, and processes, as well as critical utilities and facilities required for packaging operations at the site.

Key Responsibilities

  • Interact with several departments to provide validation support for computer systems, equipment, and processes.
  • Generate Process Performance Qualification (PPQ) documentation, including Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis, Validation Strategy, and the resulting Process Performance Qualification (PPQ).
  • Implement and review protocols for controlled temperature units (Freezers and Coldrooms) and packaging equipment.
  • Perform risk assessment and mitigation to support the attainment and maintenance of a validated state of compliance for all equipment, processes, materials, and facilities.
  • Analyze validation test data to determine whether systems or processes have met validation acceptance criteria or to identify root causes of production problems.
  • Work closely with engineering to coordinate and execute Factory Acceptance Testing (FAT) activities and protocols.

Requirements

  • A four-year, Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline.
  • 2+ years of validation experience in a regulated industry or equivalent validation experience including five years of food or pharmaceutical packaging or cGMP experience.
  • Knowledge of Controlled Temperature Unit Operation and Management.
  • PC literacy including the ability to generate complex documents in both Microsoft Excel and Microsoft Word.
  • Must be able to multitask and respond to shifting priorities.
  • Must have prior mechanical and process equipment experience.
  • Proficient with Mini-Tab or similar statistical analysis software.
  • Knowledge of pharmaceutical packaging materials and packaging equipment.

About Thermo Fisher Scientific

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.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement, and a range of other employee benefits.



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