Senior Specialist, Project Engineering

2 weeks ago

Toronto, Ontario, Canada AtkinsRéalis Full time
Senior CQV Specialist – Casual
AtkinsRéalis is dedicated in engineering a better future for our planet and its people.

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 senior level support to the CQV group to meet department goals and objectives.
The opportunity to work on various major projects for internal and external clients.
Competitive pay, flexible benefits, an employee share plan, and a defined contribution pension plan.
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; Strong working knowledge of statistics and analysis tools.

able to consult/advocate on technical and regulatory issues.
Proficient in English (oral/written), French knowledge (an asset).
Apply today and join our team to help engineer a Better Future for our Planet and its People.

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.

Please consult ourPrivacy Noticeon our Careers site to know more about how we collect, use, and transfer your Personal Data.

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' s 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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