Senior Manufacturing Validation Lead – Flexible Hours

Almac Group (Uk) Ltd; Greater London; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Annual bonuses

Generous holiday allowance

Healthcare reimbursement scheme

Job summary

Almac Pharma Services in the UK is seeking a Senior Technical Specialist – Manufacturing Validation to own product and process validation, including PPQ campaigns, CPV, and data integrity. You will work closely with Manufacturing Operations and the wider Technical Operations Group to ensure robust, inspection-ready validated processes at the Charnwood site.

You’ll lead or participate in equipment and facility qualification using DQ–IQ–OQ–PQ, write URS and technical specs, conduct risk

Qualifications

• Proven process validation experience in GMP drug product (OSD preferred).
• PPQ leadership and CPV experience.
• Familiarity with FDA 2011 PV, EU GMP Annex 15, ICH Q8/Q9/Q10.

Responsibilities

• Lead PPQ: author/approve protocols, sampling plans and acceptance criteria; oversee execution and reporting.
• Lead equipment and facility qualification lifecycle using DQ–IQ–OQ–PQ; maintain validated state.
• Generate URS, specifications, Risk Assessments, Traceability Matrix, IQ/OQ protocols and summaries.
• Lead deviation/CAPA and Quality Risk Management activities; manage validation impact assessments.
• Represent validation in audits and regulatory inspections; defend strategy and reports.
• Collaborate with QA, Analytical/QC, Engineering and Production to execute qualifications.
• Coordinate end-to-end validation and data integrity across lifecycle.

Skills

Experience in GMP validation

Regulatory knowledge (FDA EU ICH)

Statistics & tools (Minitab/JMP)

Quality systems (TrackWise)

Cross-functional collaboration

Education

Degree in Life Science or Engineering

Tools

Minitab

JMP

TrackWise

Job description

Almac Pharma Services in the UK is seeking a Senior Technical Specialist – Manufacturing Validation to own product and process validation, including PPQ campaigns, CPV, and data integrity. You will work closely with Manufacturing Operations and the wider Technical Operations Group to ensure robust, inspection-ready validated processes at the Charnwood site.

You’ll lead or participate in equipment and facility qualification using DQ–IQ–OQ–PQ, write URS and technical specs, conduct risk