Process Engineer (CQV & Capital Projects)

Our client is seeking an experienced Process Engineer to support a portfolio of capital projects involving the introduction of new manufacturing equipment and modifications to existing process systems.

This role sits at the front end of the project lifecycle, ensuring process requirements are clearly defined and translated into equipment designs, qualification strategies and validation documentation. The successful candidate will combine strong process engineering knowledge with practical CQV experience to support compliant project delivery within a GMP-regulated pharmaceutical environment.

Key Responsibilities

• Support capital projects involving new process equipment installations and process modifications.
• Develop User Requirement Specifications (URSs) and ensure process requirements are appropriately captured and defined.
• Liaise with engineering teams, equipment vendors and project stakeholders to ensure equipment designs meet operational and validation requirements.
• Review OEM documentation and equipment specifications to understand system functionality and critical process requirements.
• Identify and justify Critical Process Parameters (CPPs) and support the development of process control strategies.
• Contribute to commissioning, qualification and validation planning activities throughout the project lifecycle.
• Draft and review validation documentation, including risk assessments, qualification protocols and summary reports.
• Support design reviews, FATs, SATs and equipment startup activities.
• Ensure GMP requirements and risk-based validation principles are incorporated into project execution.
• Provide technical support during qualification and validation execution phases.

Requirements

• Bachelor's Degree in Chemical, Process, Mechanical or related Engineering discipline.
• 5+ years' experience in pharmaceutical process engineering, CQV or validation-focused project roles.
• Experience supporting capital projects involving new process equipment or manufacturing system upgrades.
• Strong understanding of equipment qualification, validation lifecycle activities and GMP requirements.
• Experience developing URSs and translating process requirements into equipment design specifications.
• Familiarity with identifying Critical Process Parameters (CPPs) and supporting process validation activities.
• Ability to interpret equipment drawings, technical specifications and OEM documentation.
• Strong stakeholder management and communication skills.
• Experience within pharmaceutical, biotech or other highly regulated manufacturing environments.

Desirable

• Exposure to FAT, SAT, commissioning and startup activities.
• Experience supporting process design and equipment implementation projects.