Senior Manufacturing Validation Specialist - Flexible Hours

Almac Group; Loughborough; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Generous holiday allowance

Healthcare reimbursement

Job summary

Almac Group in the United Kingdom is seeking a Senior Technical Specialist in Manufacturing Validation to own PPQ campaigns and CPV for commercial products at the Charnwood site. You will ensure processes stay validated and inspection-ready, collaborating with Manufacturing Operations and the Technical Operations Group.

The role requires proven GMP validation experience, strong CPV leadership, and ability to drive QA life-cycle tasks using DQ–IQ–OQ–PQ processes across equipment and facilities.

Qualifications

• Proven GMP validation experience in drug product
• PPQ leadership and CPV experience
• Knowledge of FDA PV guidance and EU Annex 15
• Familiarity with ICH Q8/Q9/Q10 and regulatory expectations
• Experience with quality systems and data integrity principles
• Ability to lead cross-functional validation projects and timelines

Responsibilities

• Lead PPQ: protocols, sampling plans, acceptance criteria, and PPQ summaries
• Oversee equipment and facility qualification using DQ–IQ–OQ–PQ
• Prepare URS, FS, and risk assessments with QA and EW teams
• Lead deviation/CAPA and validation impact assessments
• Represent validation strategy in audits and regulatory inspections
• Collaborate with QA, Analytical/QC, Engineering, Production on qualifications
• Coordinate end-to-end validation including cleaning validation

Skills

cGMP manufacturing

CAPA Management

System Validation

PPQ

Education

Life Science or Engineering degree

Job description

Almac Group in the United Kingdom is seeking a Senior Technical Specialist in Manufacturing Validation to own PPQ campaigns and CPV for commercial products at the Charnwood site. You will ensure processes stay validated and inspection-ready, collaborating with Manufacturing Operations and the Technical Operations Group.

The role requires proven GMP validation experience, strong CPV leadership, and ability to drive QA life-cycle tasks using DQ–IQ–OQ–PQ processes across equipment and facilities.