Validation Engineering Specialist III

1 week ago


Mississauga, Ontario, Canada Thermo Fisher Scientific Full time
Job Description

As a key member of our team, you will provide specialized validation knowledge and information to support operations and clients. Your expertise will be essential in ensuring that equipment and facilities processes meet the highest standards of quality and compliance. You will be responsible for reviewing and approving documents, providing guidance to junior members, and leading complex validation projects. Your strong leadership skills and attention to detail will be crucial in driving project success and maintaining a safe working environment.

Key Responsibilities:
  1. Provide leadership and guidance to junior members on validation requirements and processes.
  2. Review and approve documents, including URS, FS, DS, HS, FAT, SAT, and vendor documentation.
  3. Lead complex validation projects, including risk assessment, HAZOP, FMEA's, and Validation plans.
  4. Develop and lead project timelines, resources, and budgets.
  5. Attend client meetings and represent the company as a validation expert.
  6. Update assigned Master Validation Plans (MVPs) and maintain a safe working environment.
  7. Act as a Subject Matter Expert during audits and regulatory inspections.
Requirements:

Education:

Postsecondary diploma in Engineering, Science, or related field. Engineering Degree is an asset.

Experience:

Minimum 5 years experience in validation within the pharmaceutical industry. Previous experience in project management is an asset.

Skills and Abilities:

Strong written and oral communication skills. Detail-oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills, with the ability to work collaboratively with team members. Strong judgment, decision-making, and problem-solving skills. Ability to multi-task and meet tight deadlines in a fast-paced environment.



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