Process Engineer (CQV)
- Lunenburg, NS, Canada
Full-time
Applications open in a new tab.
Job details
- Job type
- Full-time
- Apply by
- Experience
- Minimum 5 years' experience in Commissioning, Qualification and Validation (CQV) within a regulated pharmaceutical environment.
- Posting language
- English
- Posted
Original job description
Our Client is seeking a Process Engineer to support capital projects on site, providing technical oversight of Commissioning, Qualification and Validation (CQV) activities. The successful candidate will ensure process requirements, GMP principles and risk-based methodologies are appropriately applied throughout project delivery, maintaining compliance and inspection readiness.
Key Responsibilities
- Provide technical oversight and review of CQV documentation, including commissioning plans, risk assessments, qualification protocols and reports.
- Ensure process requirements are effectively translated into GMP-compliant design and qualification strategies.
- Support the identification, justification and control of critical quality attributes (CQAs) and critical process parameters (CPPs).
- Apply risk-based approaches to determine qualification scope, testing requirements and verification activities.
- Review and approve CQV strategies, plans and lifecycle documentation.
- Challenge and guide project teams, vendors and CQV service providers to ensure regulatory and industry best practice compliance.
- Support design reviews, change controls and deviation investigations from a technical compliance perspective.
- Ensure systems remain in a validated state and support ongoing inspection readiness.
- Bachelor's degree in Engineering (Chemical, Mechanical, Electrical or related discipline).
- Minimum 5 years' experience in Commissioning, Qualification and Validation (CQV) within a regulated pharmaceutical environment.
- Strong understanding of pharmaceutical manufacturing processes, CQAs and CPPs.
- Working knowledge of GMP regulations and industry standards, including EU GMP, FDA and ICH guidelines.
- Experience reviewing and approving CQV lifecycle documentation.
- Strong risk assessment, problem-solving and analytical skills.
- Excellent stakeholder management and communication abilities.
- Ability to identify, assess and escalate compliance and quality risks.
More about this job
Responsibilities
Provide technical oversight and review of CQV strategies, plans, risk assessments, qualification protocols, reports, and lifecycle documentation for capital projects. Ensure process requirements and risk-based approaches are applied in GMP-compliant design and qualification, while supporting change controls, deviation investigations, validated-state maintenance, and inspection readiness.
Requirements
Requires a bachelor's degree in engineering and at least five years of CQV experience in a regulated pharmaceutical environment. Candidates should understand pharmaceutical manufacturing, CQAs and CPPs, GMP regulations and EU GMP, FDA, and ICH guidance, and have strong documentation review, risk assessment, problem-solving, analytical, and stakeholder communication skills.
Skills
- Commissioning, Qualification, And Validation (CQV)
- GMP Compliance
- Pharmaceutical Manufacturing Processes
- Critical Quality Attributes (CQAs)
- Critical Process Parameters (CPPs)
- Risk Assessment
- CQV Documentation Review
- Qualification Protocols
- Design Reviews
- Change Control
- Deviation Investigations
- Stakeholder Management
- Problem-Solving
- Analytical Skills
- Inspection Readiness
Visa sponsorship
Not detected in the job text
Categories
- Engineering
- Manufacturing
- Healthcare
Keywords
- Commissioning, Qualification, And Validation (CQV)
- Good Manufacturing Practice (GMP)
- EU GMP
- FDA Guidelines
- ICH Guidelines
- Pharmaceutical Manufacturing
- Capital Projects
- Process Requirements
- Critical Quality Attributes (CQAs)
- Critical Process Parameters (CPPs)
- Risk-Based Methodologies
- Risk Assessments
- Qualification Protocols
- Commissioning Plans
- CQV Strategies
- Lifecycle Documentation
- GMP-Compliant Design
- Design Reviews
- Change Control
- Deviation Investigations
- Validated State
- Inspection Readiness
- Regulatory Compliance
- Quality Risk Management