Senior Commissioning, Qualification and Validation Specialist
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Founded in 1911, SNC-Lavalin is one of the leading engineering and construction groups in the world and a major player in the ownership of infrastructure. From offices in over 50 countries, SNC-Lavalin's approximately 40,000 employees provide EPC and EPCM services to clients in a variety of industry sectors, including oil and gas, mining and metallurgy, environment and water, infrastructure and power. SNC-Lavalin can also combine these services with its financing and operations and maintenance capabilities to provide complete end-to-end project solutions.
The Senior CQV Specialist provides technical and project leadership with a comprehensive understanding of pharmaceutical industry design/build/validation processes and how they related to Canadian, E.U., and U.S FDA cGMP regulation requirements. Consultation with client and project team members from Engineering, Quality, and Manufacturing is also required to ensure that the design, implementation, and qualification of equipment, systems, and processes is conducted according to established quality standards through lifecycle management.
- Develops/reviews technical documentation pertaining to systems and processes including:
- Impact and Critical Aspect Assessment Impact, Pre-move Test documentation, and Commisionning Test packs
- User Requirements Specifications
- Commissioning protocols, and Factory and Site Acceptance Tests
- Risk Assessments and Gap Analyses
- Qualification and Validation Protocols and Reports
- Standard Operating Procedures
- Validation Master Plans
- Quality Plans and Policies
- Strategizes approaches to meet requirements and guidance
- Coordinates and executes testing of systems and processes from test protocols
- Analysis of test data, including that derived from complex processes
- Troubleshoots issues of diverse scope where analysis of data requires evaluation of identifiable factors.
- Provides support or training to client on validation policies and procedures.
- Provides senior level support to the Validation group to meet department goals and objectives.
- Bachelors degree in an engineering or scientific discipline (e.g. chemistry, biochemistry).
- 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 and process validation.
- Minimum 8 years experience with specialized expertise in one or more of the following:
- qualifying equipment and systems: eg. incubators, autoclaves, clean utilities, computerized systems, clean utilities, etc; and/or
- Cleaning Validation experience; and/or
- Process Validation experience
- Strong knowledge of utilities, cleaning validation, and general production systems used in pharmaceutical manufacturing. Knowledge and experience with automated/computerized systems is an asset.
- Strong working knowledge of statistics and analysis tools.
- Strong word processing and spreadsheet skills, including processing of formulas.
- Excellent verbal and written communication skills; able to consult/advocate on technical and regulatory issues.
- Excellent customer service skills.
- Well organized, self-motivated, and able to work both independently and within a team environment.
- Flexible with the proven ability to prioritize and work to deadlines.
- Some travel may be required, although the bulk of work is expected to be in the Greater Toronto Area.
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 SNC-Lavalin’s accommodation policies at the time the employment offer is extended, and the information will be shared with new personnel during the onboarding process.
Founded in 1911, SNC-Lavalin is a global fully integrated professional services and project management company and a major player in the ownership of infrastructure. From offices around the world, SNC-Lavalin's employees are proud to build what matters. Our teams provide comprehensive end-to-end project solutions – including capital investment, consulting, design, engineering, construction, sustaining capital and operations and maintenance – to clients in oil and gas, mining and metallurgy, infrastructure and power. On July 3, 2017, SNC-Lavalin acquired Atkins, one of the world's most respected design, engineering and project management consultancies. http://www.snclavalin.com
At SNC-Lavalin, 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.