Senior CQV Specialist

Job Description

Come join us in reshaping the future with Atkins Ralis.

Atkins Ralis is dedicated to engineering a better future for our planet and its people.

Your role within the team:
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.

• 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.

• 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 demonstrating knowledge of validation principles, including validation planning, user requirement and functional specifications, commissioning, IQ, OQ, PQ.
• Specialized expertise in one or more of the following:
  Qualifying equipment and systems (incubators, autoclaves, clean utilities, computerized systems, etc.).
• Cleaning and process Validation experience.
• Strong knowledge of utilities and general production systems used in pharmaceutical manufacturing.
• Solid 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.

• Competitive pay, flexible benefits, an employee share plan, and a defined contribution pension plan.
• Work environment focused on health and safety.
• Wide array of learning and development opportunities.
• Work-life balance is important.

We strongly believe that world-class talent makes no distinctions based on gender, ethnicity or national origin, sexual identity and orientation, age, religion or disability, but enriches itself through these differences.

Are you up for this challenge? Apply today and join our team to help engineer a Better Future for our Planet and its People.