Validation Engineering Specialist III

2 weeks ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Inc. Full time
Job DescriptionAbout the Job

We are seeking a skilled Validation Engineering Specialist III to join our team at Thermo Fisher Scientific Inc.

Key Responsibilities
  • Provide specialized validation knowledge and information to support operations and clients.
  • Finish the protocols related to the validation of equipment and facilities processes and review all finished reports prior to final approval.
  • Ensure documents conform to all SOPs, client requirements and Good Manufacturing Practices.
  • Lead complex URS, FS, DS, HS, FAT, SAT document generation, review, and approval.
  • Develop and lead project timelines, resources, and budgets for both minor and major projects.
  • Review and approve vendor documentation, change controls and maintenance reports.
  • Lead risk assessment, HAZOP, FMEA's and Validation plans for Equipment, Systems & Facilities for unique processes and equipment procured in Processing, Packaging & PPT areas.
  • Attend client meetings as validation representative (as required).
  • Update assigned Master Validation Plans (MVPs) as per validation policy.
  • Act as Subject Matter Expert during audit and regulatory inspections. Lead audit responses and assessment.
Requirements
  • Post secondary diploma in Engineering, Science, or related field. Engineering Degree is an asset.
  • Minimum 5 years experience in validation within the pharmaceutical industry. Previous experience in project management.
  • Strong written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness.
  • Excellent interpersonal skills, communication, and organizational skills.
  • Strong judgment, decision making and trouble shooting skills.
  • Ability to multi-task, meeting tight deadlines in a fast-paced environment.
  • Mini-T and data analysis knowledge an asset.
Standards and Expectations
  • Follow all Environmental Health & Safety Policies and Procedures.
  • Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives.
  • Carry out all duties within strict compliance to Thermo Fisher Scientific Inc. quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP).

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