Senior Validation Consultant

6 days ago


Calgary, Alberta, Canada AtkinsRéalis Full time

Job Overview

We are seeking a Senior Validation Consultant to join our team at AtkinsRéalis. This is an exciting opportunity to work on various major projects for internal and external clients.

About the Role

The ideal candidate will have a thorough knowledge of cGMP and regulatory requirements for validation, as well as minimum 8 years relevant work experience demonstrating knowledge of validation principles, including validation planning, user requirement and functional specifications, commissioning, IQ, OQ, PQ.

About Us

AtkinsRéalis is dedicated to engineering a better future for our planet and its people. We offer a wide array of learning and development opportunities, competitive pay, flexible benefits, an employee share plan, and a defined contribution pension plan.

Responsibilities

  1. Provides 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.
  2. 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.
  3. Coordinate and execute testing of systems and processes from test protocols to assess compliance against requirements.
  4. Analysis of test data, including that derived from complex processes, and collection of samples, where required.
  5. Operation of testing equipment.
  6. Troubleshoots issues of diverse scope where analysis of data requires evaluation of identifiable factors.
  7. Provide recommendations on equipment/process operation/optimization.
  8. Provide senior level support to the CQV group to meet department goals and objectives.

Requirements

  • Bachelor's degree in chemical or mechanical Engineering or a related Science program.
  • 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.

Benefits

  • The opportunity to work on various major projects for internal and external clients.
  • An exciting environment where work-life balance is important.
  • A wide array of learning and development opportunities.
  • Competitive pay, flexible benefits, an employee share plan, and a defined contribution pension plan.
  • A work environment focused on health and safety.

Estimated Salary: $110,000 - $140,000 per year based on location and experience.

About Us
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