Process Validation Lead - Tech Transfer & GMP Expert

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

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