Why join us?
These positions are based out of our office in Toronto and report to the Commissioning Qualification & Validation Manager. We are looking for individuals in 3 levels of experience:
Commissioning, Qualification, Validation Specialist
This position is responsible for consulting with clients in testing and coordinating building systems and equipment.
Intermediate, Commissioning, Qualifications, and Validation Specialist
This position is responsible to consult with clients in developing engineering compliance solutions, particularly in testing and documentation review of equipment, systems, and processes.
Senior Commissioning, Qualification, and Validation Specialist
This position 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.
How will you contribute to the team?
Commissioning, Qualification, Validation Specialist
- Assessment of suitability of bio-pharmaceutical equipment and processes, via structured testing and analysis
- Generation/execution of equipment validation protocols and reports for clients in regulated industries.
- Analysis of test data, reporting of results
- Provide support in troubleshooting
- Provide recommendations on equipment operation/optimization.
- Provides support or training to client on system operating procedures.
- Provides general support to the CQV group to meet department goals and objectives
Intermediate Commissioning, Qualification, and Validation Specialist
- Generation / execution of System Impact and Critical Aspect Assessment Impact, Pre-move Test documentation, and Commissioning Test packs.
- Generation / execution of equipment and/or process validation protocols and reports, including gap analysis of existing protocols against industry standards.
- Analysis of test data.
- 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 general support to the CQV group to meet department goals and objectives.
Senior Commissioning, Qualification, and Validation Specialist
- Develops/reviews technical documentation pertaining to systems and processes including:
- Impact and Critical Aspect Assessment Impact, Pre-move Test documentation, and Commissioning 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.
What will you contribute?
Commissioning, Qualification, Validation Specialist
- Bachelor’s Degree required, preferably in an Engineering field (Chemical), or related Science Program
- Experience in a GMP environment an asset
- Experience in a Quality Assurance role an asset, not required
- Excellent verbal and written communication skills, including strong attention to detail regarding documentation is a must
- Proficient in English (oral/written), French knowledge (an asset)
- Well organized, self-motivated, and able to work both independently and within a team environment.
- Knowledge of automated and computerized systems used in industrial settings a definite asset (Facility Monitoring/Building Automation preferred; PLC/SCADA and plant floor automation an asset).
- Excellent customer service skills
- Flexible with the proven ability to prioritize and work to deadlines
- Must be willing to travel and have a valid driver’s license
Intermediate Commissioning, Qualification, and Validation Specialist
- Bachelor’s Degree in Chemical Engineering or Bachelor of Science in Chemistry is required.
- 5 plus years’ experience in validation in a pharmaceutical or agri-food environment. We will consider recent graduates with experience from co-op or internships.
- Professional Engineer (an asset).
- Working knowledge of utilities, cleaning validation, and general production systems used in pharmaceutical manufacturing (an asset).
- Experience in a Quality Assurance role an asset, not required
- Excellent verbal and written communication skills, including strong attention to detail regarding documentation is a must.
- Proficient in English (oral/written), French knowledge (an asset).
- Well organized, self-motivated, and able to work both independently and within a team environment.
- Knowledge of automated and computerized systems used in industrial settings a definite asset (PLC/SCADA. Lab systems, etc.).
- Excellent customer service skills.
- Flexible with the proven ability to prioritize and work to deadlines.
- Must be willing to travel and have a valid driver’s licence.
Senior Commissioning, Qualification, and Validation Specialist
- Bachelor’s 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: Ex, 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.
What we offer at SNC-Lavalin:
At SNC-Lavalin, you will enjoy competitive compensation, a safe and healthy work environment, and a full range of benefits (ie.: group insurance, retirement savings plan, share purchase plan, continuing education program, etc.).
- Opportunity to work on various projects of various sizes
- Competitive salary
- Motivational financial package & flexible benefits
- Defined contribution pension plan in which SNC-Lavalin contributes
- Work equipment provided according to the season (boot, bib, helmet, gloves, etc.);
- Employee Share Ownership Plan (ESOP)
- Employee Assistance Program (EAP)
- 3 weeks of vacation time
- Learning and Development programs, training, career opportunities
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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 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.
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.
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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
