Senior Validation Specialist

7 days ago

Calgary, Alberta, Canada AtkinsRéalis Full time

Job Title: Senior CQV Specialist

About the Role:

We are seeking a highly skilled Senior CQV Specialist to join our team at AtkinsRéalis. As a Senior CQV Specialist, you will be responsible for providing 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.

Key Responsibilities:

  • Develops/reviews 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.
  • Analysis of test data, including that derived from complex processes, and collection of samples, where required.
  • Operation of testing equipment.
  • Troubleshoots 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.

Why Choose AtkinsRéalis?

AtkinsRéalis offers a dynamic work environment where you can work on various major projects for internal and external clients. We prioritize work-life balance, provide a wide array of learning and development opportunities, and offer competitive pay, flexible benefits, an employee share plan, and a defined contribution pension plan.

Requirements:

  • Bachelor's degree in chemical or mechanical Engineering or a related Science program.
  • Thorough knowledge of cGMP and regulatory requirements for validation.
  • Minimum of 8 years relevant work experience which demonstrates knowledge of validation principles, including: validation planning, user requirement and functional specifications, commissioning, IQ, OQ, PQ; with specialized expertise in one or more of the following:
  • Qualifying equipment and systems: e.g. incubators, autoclaves, clean utilities, computerized systems, etc.
  • Cleaning and process Validation experience.
  • Strong knowledge of utilities and general production systems used in pharmaceutical manufacturing.
  • Strong working knowledge of statistics and analysis tools.
  • Excellent verbal and written communication skills; able to consult/advocate on technical and regulatory issues.
  • Proficient in English (oral/written), French knowledge (an asset).
  • Must be mobile within the Calgary Area.

AtkinsRéalis is an Equal Opportunities Employer

We are committed to creating a diverse and inclusive work environment where everyone feels valued and respected. We welcome applications from individuals with diverse characteristics, backgrounds, and perspectives.

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