Senior CQV Specialist

Responsibilities

• Provides technical and project leadership with comprehensive understanding of pharmaceutical industry design/build/validation processes and their relation to Canadian, EU, and US FDA cGMP regulation requirements.
• Develops and 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, SOPs and quality plans and policies.
• Coordinates and executes testing of systems and processes from test protocols to assess compliance against requirements.
• Analyzes test data, including that derived from complex processes, and collects samples where required.
• Operates testing equipment.
• Troubleshoots issues of diverse scope where data analysis requires evaluation of identifiable factors.
• Provides recommendations on equipment/process operation and optimization.
• Provides senior level support to the CQV group to meet department goals and objectives.

• Bachelor's degree in chemical or mechanical Engineering or 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; 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.

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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.

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

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