Senior Validation Specialist
4 weeks ago
Job Title: Senior Validation Specialist
About the Role:
We are seeking a highly skilled Senior Validation Specialist to join our team at AtkinsRéalis. As a Senior Validation 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?
We offer a wide array of learning and development opportunities, competitive pay, flexible benefits, an employee share plan, and a defined contribution pension plan. Our work environment is focused on health and safety, and we prioritize work-life balance.
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.
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