Process Validation Lead

Next Phase Recruitment; Newry; On-site; GBP 70,000 - 95,000; Full time

Job summary

Next Phase Recruitment is seeking an experienced Process Validation Lead to support transfer of new products into commercial manufacturing and ongoing lifecycle support for established products. You will work cross-functionally across Development, Technical Services, Engineering, Quality, Regulatory Affairs and Manufacturing Operations, applying expertise in validation, PPQ, and process control strategies.

The role involves leading validation activities, authoring protocols and reports, and

Qualifications

• Degree in a scientific, pharmaceutical, engineering or related discipline.
• Experience in a GMP-regulated pharmaceutical or life sciences environment.
• Practical experience of process validation and regulatory requirements.
• Experience authoring and reviewing technical documentation (protocols/reports).
• Strong data interpretation and risk-based decision making.

Responsibilities

• Lead and support process validation activities across development and commercial manufacturing.
• Prepare, review and approve validation protocols, reports, SOPs and master plans.
• Collaborate with Development, Technical Services, Engineering, Quality and Regulatory teams to establish control strategies.
• Support equipment qualification activities and PPQ studies with risk assessments.
• Review manufacturing process documentation for alignment with formulations and regulatory submissions.
• Provide technical expertise during investigations of deviations, CAPAs, OOS and OOT results.
• Support introduction of new products into manufacturing and tech transfer oversight.
• Act as SME for validation activities across manufacturing, packaging and facilities.
• Provide regulatory support on validation matters and participate in project meetings.
• Support scale-up from development to commercial manufacture and drive continuous improvement.

Skills

Process validation

Technology transfer

GMP compliance

Manufacturing support

Validation protocols

Risk assessment

Data interpretation

Regulatory awareness

Microsoft Office

Process engineering

Education

Science/Engineering degree

Pharmaceutical qualification

Tools

Microsoft Office

Job description

We are seeking an experienced Process Validation Lead to join a growing pharmaceutical manufacturing organisation. This is a key technical role supporting the transfer of new products into commercial manufacturing, while also providing ongoing lifecycle support for established products.

The successful candidate will bring strong expertise in process validation, technology transfer, GMP compliance, and manufacturing support, working cross-functionally across Pharmaceutical Development, Technical Services, Engineering, Quality, Regulatory Affairs and Manufacturing Operations.

Key Responsibilities

• Lead and support process validation activities across development and commercial manufacturing programmes.
• Prepare, review and approve validation protocols, reports, SOPs, master plans and supporting technical documentation.
• Collaborate with Process Development, Technical Services, Engineering, Health & Safety and Quality teams to establish robust process control strategies.
• Support equipment qualification activities, process performance qualification (PPQ) studies and associated risk assessments.
• Review manufacturing process documentation to ensure alignment with approved formulations and regulatory submissions.
• Provide technical expertise during investigations relating to deviations, CAPAs, out-of-specification (OOS) and out-of-trend (OOT) results.
• Support the introduction of new products into manufacturing and provide technical oversight throughout technology transfer activities.
• Act as a subject matter expert for validation activities, including:
• Manufacturing process validation
• Packaging process validation
• Facility and computerised system validation
• Provide technical support to Regulatory Affairs on validation-related matters.
• Participate in project and customer meetings to ensure projects remain aligned with agreed timelines and objectives.
• Support scale-up activities from development through to commercial manufacture.
• Identify and implement continuous improvement initiatives focused on process efficiency, yield improvement, cycle time reduction and cost optimisation.
• Ensure all activities are conducted in compliance with current GMP requirements, EHS standards and applicable regulatory expectations.
• Maintain awareness of current international regulatory guidance and industry best practices relating to process validation.
• Degree qualified in a Scientific, Pharmaceutical, Engineering or related discipline.
• Experience working within a GMP-regulated pharmaceutical or life sciences environment.
• Practical experience of process validation and associated regulatory requirements.
• Experience authoring and reviewing technical documentation, including protocols and reports.
• Strong understanding of data interpretation, investigation processes and risk-based decision making.
• Working knowledge of VICH guidelines.
• Proficient in Microsoft Office applications.
• Process Engineering or Chemical Engineering background.
• Experience supporting technology transfer and scale-up activities.
• Previous experience transferring products from development into commercial manufacture.
• Experience across multiple pharmaceutical dosage forms.
• Additional experience within pharmaceutical development, technical services or manufacturing support functions.

Additional Information

• This manufacturing facility handles penicillin products. Therefore, the role may not be suitable for individuals with a penicillin allergy.
• Applicants must have the right to work in the UK at the time of application.