Senior Validation Specialist – Manufacturing & PPQ Lead

Almac Group; Sharnford; On-site; GBP 70,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Generous holiday allowance

Healthcare reimbursement scheme

Job summary

Almac Pharma Services in the United Kingdom is seeking a Senior Technical Specialist for Manufacturing Validation to own PPQ campaigns and ensure robust CPV for commercial products at our Charnwood site.

You will lead equipment and facility qualification using DQ–IQ–OQ–PQ, maintain validated state, and collaborate across QA, Engineering and Production to deliver inspections-ready validation reports.

Qualifications

• Proven process validation experience in GMP drug products, including PPQ leadership and CPV.
• Strong regulatory knowledge of FDA PV, EU GMP Annex 15 and ICH guidelines.
• Experience writing robust validation protocols and reports.

Responsibilities

• Lead PPQ campaigns: protocols, sampling plans, data analysis and PPQ summaries.
• Lead equipment and facility qualification lifecycle for GMP equipment (DQ–IQ–OQ–PQ).
• Prepare URS, specifications, risk assessments, and traceability matrices.
• Lead deviation/CAPA and validation impact assessments for changes.
• Represent validation in audits and inspections, defending strategy and reports.
• Collaborate with QA, Engineering, Production to execute qualifications.
• Coordinate end-to-end validation activities and data integrity across lifecycle.

Skills

Process validation

Regulatory knowledge

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in Life Science or Engineering

Tools

Minitab/JMP

eQMS TrackWise

ALCOA/Data integrity

Job description

Almac Pharma Services in the United Kingdom is seeking a Senior Technical Specialist for Manufacturing Validation to own PPQ campaigns and ensure robust CPV for commercial products at our Charnwood site.

You will lead equipment and facility qualification using DQ–IQ–OQ–PQ, maintain validated state, and collaborate across QA, Engineering and Production to deliver inspections-ready validation reports.