Senior CQV Specialist

AtkinsRéalis; Calgary; On-site; CAD 80,000 - 100,000; Full time

Job summary

At AtkinsRéalis, join a dynamic team focused on engineering a better future. This role requires extensive knowledge in the pharmaceutical industry, specifically around validation processes and regulatory requirements. With a strong focus on technical leadership, the ideal candidate will assist in developing essential documentation and ensuring compliance with industry standards, creating a supportive work environment that emphasizes work-life balance and professional growth.

Benefits

Learning and development opportunities

Flexible benefits

Employee share plan

Defined contribution pension plan

Health and safety focused environment

Qualifications

• Minimum of 8 years relevant work experience in validation principles.
• Strong knowledge of utilities and production systems in pharmaceutical manufacturing.
• Proficient in English; French knowledge is an asset.

Responsibilities

• Provides technical and project leadership in validation processes.
• Develops technical documentation for compliance in regulated industries.
• Analyzes test data and troubleshoots equipment issues.

Skills

Communication

Statistics

Regulatory Knowledge

Problem Solving

Education

Bachelor’s degree in chemical or mechanical engineering

Job description

Come join us in reshaping the future with AtkinsRéalis. AtkinsRéalis is dedicated in engineering a better future for our planet and its people.

Please note that this job posting aims to create a pool of candidates for future needs.

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.

Why choose AtkinsRéalis as an employer?

Because we offer:

• 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.

The ideal candidate:

• 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.

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

At AtkinsRéalis, we seek to hire individuals with diverse characteristics, backgrounds, and perspectives. We strongly believe that world-class talent makes no distinctions based on gender, ethnic or national origin, sexual identity and orientation, age, religion, or disability, but enriches itself through these differences.

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