Process Validation Lead

Process Validation Lead

An established pharmaceutical manufacturing organisation is seeking a Process Validation Lead to support new product introductions, technology transfer and ongoing commercial manufacturing. This role will drive validation activities, ensure GMP compliance and improve manufacturing performance through cross-functional collaboration.

Key Responsibilities

• Lead process validation programmes.
• Author validation protocols and reports.
• Support technology transfer activities.
• Oversee PPQ and equipment qualification.
• Manage deviations, CAPAs and investigations.
• Review manufacturing and technical documentation.
• Provide validation regulatory support.
• Support scale-up and product launches.
• Drive process improvement initiatives.
• Maintain GMP and regulatory compliance.

Essential Requirements

• Degree in a relevant scientific, pharmaceutical or engineering discipline.
• Experience in GMP-regulated pharmaceutical manufacturing.
• Practical process validation experience.
• Strong technical writing and documentation skills.
• Knowledge of risk assessment and investigations.
• Working knowledge of VICH guidelines.
• Proficiency in Microsoft Office.
• Applicants must have the right to work in the UK.

Location : Northern Ireland