Process Engineer (CQV)

DPS Group; Leinster; On-site; EUR 70,000 - 100,000; Full time

Job summary

DPS Group is seeking a Process Engineer to support capital projects on site, providing technical oversight of CQV activities. The role ensures GMP principles, CQAs and CPPs are applied and that project deliverables meet regulatory and inspection-readiness requirements.

You will review CQV documentation, collaborate with project teams and vendors, and translate process requirements into compliant qualification strategies while maintaining validated state across systems.

Qualifications

• 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.

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.

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 escalate compliance and quality risks.