Pharmaceutical Validation Expert

5 days ago

Calgary, Alberta, Canada AtkinsRéalis Full time

At AtkinsRéalis, we are seeking a highly skilled Pharmaceutical Validation Expert to join our team in Calgary. As a key member of our CQV group, you will provide technical leadership and project expertise to our clients in the pharmaceutical industry.

About the Role

The ideal candidate will have a Bachelor's degree in Chemical or Mechanical Engineering or a related Science program and a minimum of 8 years of relevant work experience. You will have thorough knowledge of cGMP and regulatory requirements for validation, including qualification and validation protocols and reports, criticality assessments, risk assessments, validation master plans, user requirements specifications, standard operating procedures, and quality plans and policies.

Responsibilities
  • Provide technical and project leadership with a comprehensive understanding of the pharmaceutical industry design/build/validation processes and how they relate to Canadian, EU, and US FDA cGMP regulation requirements.
  • Develop/review technical documentation for clients in regulated industries, including qualification and validation protocols and reports, criticality assessments, risk assessments, validation master plans, user requirements specifications, standard operating procedures, and quality plans and policies.
  • Coordinate and execute testing of systems and processes from test protocols to assess compliance against requirements.
  • Analyze test data, including that derived from complex processes, and collect samples where required.
  • Operate testing equipment.
  • Troubleshoot issues of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Provide recommendations on equipment/process operation/optimization.
  • Provide senior-level support to the CQV group to meet department goals and objectives.
About Us

AtkinsRéalis is dedicated to engineering a better future for our planet and its people. We offer a competitive salary range of $120,000 - $160,000 per year, depending on experience, plus flexible benefits, an employee share plan, and a defined contribution pension plan. We prioritize work-life balance and provide opportunities for learning and development.

What We Offer
  • A competitive salary range of $120,000 - $160,000 per year, depending on experience.
  • Flexible benefits, including health, dental, and vision insurance.
  • An employee share plan, allowing you to share in the company's success.
  • A defined contribution pension plan, ensuring your financial security in retirement.
  • Ongoing training and development opportunities, helping you grow in your career.
  • A dynamic and supportive work environment, prioritizing work-life balance.
Requirements
  • Bachelor's degree in Chemical or Mechanical Engineering or a related Science program.
  • Minimum of 8 years of relevant work experience in pharmaceutical validation.
  • Thorough knowledge of cGMP and regulatory requirements for validation.
  • Strong communication and problem-solving skills.
  • Proficient in English (oral/written), French knowledge an asset.
  • Ability to work independently and as part of a team.
How to Apply

If you are a motivated and experienced Pharmaceutical Validation Expert looking for a new challenge, please submit your application to us.

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