Process Engineer (CQV)

Job summary

Provide technical oversight and review of CQV strategies, plans, risk assessments, qualification protocols, reports, and lifecycle documentation for capital projects. Ensure process requirements, GMP principles, and risk-based methods are applied, and support design reviews, change controls, deviation investigations, validated-state maintenance, and inspection readiness.

Job details

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.

What you’ll do

Provide technical oversight and review of CQV strategies, plans, risk assessments, qualification protocols, reports, and lifecycle documentation for capital projects. Ensure process requirements, GMP principles, and risk-based methods are applied, and support design reviews, 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 guidelines, CQV documentation, risk assessment, and effective stakeholder communication.

Listed skills

• Problem solving · Preferred
• Regulatory Compliance · Preferred
• Stakeholder Management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Commissioning, Qualification And Validation
• GMP Compliance
• Pharmaceutical Manufacturing
• Process Engineering
• Risk Assessment
• Critical Quality Attributes
• Critical Process Parameters
• CQV Documentation Review
• Qualification Strategy
• Regulatory Compliance
• Change Control
• Deviation Investigation
• Stakeholder Management
• Problem-Solving
• Analytical Skills
• Inspection Readiness

Job areas

• Engineering
• Manufacturing
• Management & Leadership