Senior CQV Specialist

1 week ago Be among the first 25 applicants

• 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 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.

Explore the rewards and benefits that help you thrive – at every stage of your life and your career at Atkins

Réalis in Canada. Enjoy competitive compensation, employee recognition, and a brilliant range of flexible benefits you can tailor to your health, wellbeing, financial and lifestyle needs. Make the most of diverse opportunities for training and professional development to grow your skills and expertise. And take advantage of our hybrid working culture and generous time-off policies to balance a fulfilling career with your personal life.

Be rewarded. Find out more.

We're Atkins

Réalis, a world-class engineering services and nuclear organization. We connect people, data and technology to transform the world's infrastructure and energy systems. Together, with our industry partners and clients, and our global team of consultants, designers, engineers and project managers, we can change the world. We're committed to leading our clients across our various end markets to engineer a better future for our planet and its people.

Additional information:
Atkins

Réalis cares about your privacy. Atkins

Réalis and other subsidiary or affiliated companies of Atkins

Réalis (referred to throughout as "Atkins

Réalis") are committed to protecting your privacy. Please consult our Privacy Notice on our Careers site to know more about how we collect, use, and transfer your Personal Data. By submitting your personal information to Atkins

Réalis, you confirm that you have read and accept our Privacy Notice.

Appropriate accommodation will be provided upon request throughout the recruitment and hiring process as required by Company policy and the Accessibility for Ontarians with Disabilities Act (AODA). Successful applicants will be notified about Atkins

Réalis' accommodation policies at the time the employment offer is extended, and the information will be shared with new personnel during the onboarding process.

Mid-Senior level

Full-time

Information Technology