Process Equipment Engineer

Our Client is seeking an experienced Process Equipment Engineer to support major capital projects on site, providing technical oversight of Commissioning, Qualification and Validation (CQV) activities throughout the project lifecycle.

This position requires a strong understanding of pharmaceutical manufacturing processes, CQV principles and GMP compliance, with particular emphasis on User Requirement Specification (URS) development and review and equipment/process design experience. The successful candidate will ensure process requirements are effectively translated into compliant design solutions and qualification strategies, maintaining regulatory compliance and inspection readiness from project conception through to handover.

Key Responsibilities

• Provide technical oversight and review of CQV documentation, including commissioning plans, risk assessments, qualification protocols and reports.
• Develop, review and challenge User Requirement Specifications (URS) to ensure operational, process and compliance requirements are clearly defined and incorporated into project deliverables.
• Ensure process requirements are effectively translated into GMP-compliant design and qualification strategies.
• Support equipment and process design activities, participating in design reviews to ensure operational, maintenance, safety and compliance requirements are incorporated from concept through detailed design.
• Support the identification, justification and control of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
• Apply risk-based methodologies 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 compliance and industry best practice.
• 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.
• Provide technical leadership throughout project execution, ensuring alignment between design intent, process requirements and qualification activities.
• Support project delivery from design and specification stages through commissioning, qualification and operational handover.

Essential 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 manufacturing environment.
• Demonstrated experience authoring, reviewing and approving User Requirement Specifications (URS) for pharmaceutical capital projects.
• Strong equipment and process design experience, including participation in design reviews and ensuring process requirements are incorporated into system and equipment design.
• Experience working across the full project lifecycle, from concept design and specification development through commissioning, qualification and operational handover.
• Strong understanding of pharmaceutical manufacturing processes, CQAs and CPPs.
• Experience reviewing and approving CQV lifecycle documentation.
• Working knowledge of GMP regulations and industry standards, including EU GMP, FDA and ICH guidelines.
• Experience supporting and reviewing change controls, deviations and risk assessments.
• Strong risk assessment, problem-solving and analytical skills.
• Excellent stakeholder management and communication abilities.
• Ability to identify, assess and escalate compliance and quality risks.

Highly Desirable

• Experience supporting large pharmaceutical capital expansion projects.
• Experience with sterile, biologics, vaccine or drug substance manufacturing facilities.
• Knowledge of ASTM E2500, ISPE Baseline Guides and modern risk-based validation approaches.
• Experience supporting FATs, SATs, design qualification and technical reviews.
• Familiarity with process equipment design, utilities and manufacturing systems.
• Experience leading multidisciplinary interactions between Engineering, Quality, Operations and Project Teams.