Senior Validation Engineering Lead

6 days ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time

Estimated salary: $120,000 - $160,000 per annum.

Job Description

This role offers a unique opportunity to join Thermo Fisher Scientific as a Senior Validation Engineer. As part of our team, you will be responsible for leading the validation process for equipment and facilities across various departments.

  • You will work closely with cross-functional teams to identify, assess, and mitigate risks associated with new equipment and processes.
  • Develop and implement effective validation protocols and procedures to ensure compliance with regulatory requirements and company standards.
  • Provide guidance and training to junior team members on validation principles, procedures, and best practices.
Key Responsibilities:
  • Lead complex validation projects from planning to execution, ensuring timely delivery and quality outcomes.
  • Collaborate with technical teams to develop and maintain validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Hazard and Operability Studies (HAZOP), and Risk Assessments.
  • Review and approve vendor documentation, change controls, and maintenance reports to ensure compliance with company standards and regulatory requirements.
  • Develop and lead project timelines, resources, and budgets for both minor and major projects.
  • Act as a subject matter expert during audits and regulatory inspections, providing clear explanations and justifications for validation processes and procedures.
Requirements:
  • Bachelor's degree in an engineering or scientific discipline, or equivalent experience.
  • Minimum 5 years of experience in validation within the pharmaceutical industry, with a strong background in project management.
  • Excellent written and verbal communication skills, with the ability to present complex information to both technical and non-technical stakeholders.
  • Strong analytical and problem-solving skills, with the ability to think critically and make sound judgments.
  • Proficiency in Microsoft Office applications, including Excel, Word, and Project.
Working at Thermo Fisher Scientific:

We are a global leader in serving science, with a commitment to innovation, customer satisfaction, and employee development. As a member of our team, you will have opportunities to grow professionally and personally, while contributing to the success of our organization.

Why Choose Us:
  • We offer a competitive salary range of $120,000 - $160,000 per annum, based on experience and qualifications.
  • A comprehensive benefits package, including medical, dental, and vision insurance, retirement plan, and paid time off.
  • Opportunities for professional growth and development, including training programs, mentorship, and career advancement.
  • A dynamic and inclusive work environment, with a focus on collaboration, innovation, and customer satisfaction.

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