Senior Validation Specialist - PPQ & Equipment (GMP)

Almac Group; Leicester; On-site; GBP 65,000 - 80,000; Full time

Job summary

Almac Pharma Services in Leicestershire, United Kingdom, is seeking a Senior Technical Specialist to drive product/process validation, PPQ campaigns and CPV for commercial products. You will lead qualification activities across equipment and facilities, maintain validated state, and collaborate with QA, Engineering and Production to ensure compliant, inspection-ready operations.

Applicants should have proven GMP PV experience, strong technical writing, and a track record of leading

Qualifications

• Proven process validation experience in GMP drug products with PPQ leadership.
• Experience with FDA PV, EU Annex 15, ICH Q8/Q9/Q10 is required.
• Strong technical writing for protocols and reports.
• Ability to lead cross-functional validation workstreams.
• Degree in Life Science or Engineering is required.

Responsibilities

• Lead PPQ: author/approve protocols, sampling plans, acceptance criteria, and PPQ reports.
• Lead equipment and facility qualification lifecycle per DQ-IQ-OQ-PQ.
• Prepare URS, functional specs, TRs, IQ/OQ, and summary reports for validation.
• Manage deviation/CAPA and validation impact assessments for changes.
• Interface with audits and represent validation in inspections.

Skills

PPQ leadership

CPV expertise

data integrity

Quality systems

cross-functional collaboration

Education

Life Science or Engineering degree

Tools

Minitab

JMP

TrackWise (eQMS)

Job description

Almac Pharma Services in Leicestershire, United Kingdom, is seeking a Senior Technical Specialist to drive product/process validation, PPQ campaigns and CPV for commercial products. You will lead qualification activities across equipment and facilities, maintain validated state, and collaborate with QA, Engineering and Production to ensure compliant, inspection-ready operations.

Applicants should have proven GMP PV experience, strong technical writing, and a track record of leading