Process Engineer (CQV)

DPS Group Global; Lunenburg; On-site; CAD 85,000 - 120,000; Full time

Job summary

DPS Group Global is seeking a Process Engineer to support capital projects on site, providing technical oversight of CQV activities to ensure GMP compliance and inspection readiness.

The role requires strong CQV experience, GMP knowledge, and the ability to apply risk-based methodologies across project delivery while collaborating with engineers, vendors and CQV providers.

Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical or related).
• Minimum 5 years' CQV experience in a regulated pharmaceutical environment.
• Strong understanding of GMP, EU GMP, FDA and ICH guidelines.
• Experience reviewing and approving CQV lifecycle documentation.
• Excellent risk assessment, problem-solving and analytical skills.
• Strong stakeholder management and communication abilities.

Responsibilities

• Provide technical oversight and review of CQV documentation, including commissioning plans, risk assessments, qualification protocols and reports.
• Ensure process requirements are translated into GMP-compliant design and qualification strategies.
• Support CQV lifecycle documentation reviews and approvals.
• Apply risk-based approaches to qualification scope, testing requirements and verification activities.
• Review and approve CQV strategies, plans and lifecycle documentation.
• Collaborate with project teams, vendors and CQV service providers to ensure regulatory and industry best practices.
• Support design reviews, change controls and deviation investigations from a technical compliance perspective.
• Ensure systems remain in a validated state and support inspection readiness.

Skills

CQV experience

GMP knowledge

Risk assessment

Stakeholder management

Communication skills

Education

Bachelor's degree in Engineering (Chemical, Mechanical, Electrical or related)

Job description

Overview

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.

Requirements

• 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 escalation compliance and quality risks.