Senior Technical Specialist – Manufacturing Validation

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

Senior Technical Specialist – Manufacturing Validation

Location: Charnwood, Loughborough, United Kingdom

Hours: 37.5 hours per week Monday to Friday. Flexible working hours

Business Unit: Almac Pharma Services

Ref No.: HRJOB11835

Why this role matters: For over 50 years Almac Pharma Services has manufactured and packed oral solid dose medicines—tablets, capsules and powders—supplying patients worldwide. An opportunity has become available to join our Manufacturing Support department in the role of Senior Technical Specialist.

In this role your primary job purpose is product/process validation, and you will own PPQ campaigns and enable robust CPV for commercial products at our Charnwood site, ensuring processes remain in a validated state and inspection‑ready at all times.

You’ll partner closely with Manufacturing Operations and the wider Technical Operations Group to turn science and data into compliant, reliable supply.

You may also lead equipment and facility qualification for GMP‑relevant equipment using DQ–IQ–OQ, ensuring systems are designed, installed, operated and perform, and continue to perform as intended.

What you’ll do

• Lead PPQ: author/approve protocols, define sampling plans and acceptance criteria, oversee execution, analyse data, and issue PPQ summary reports for timely release
• Lead or participate in equipment and facility qualification: Deliver qualification lifecycle for GMP‑relevant equipment using DQ–IQ–OQ-PQ and maintain equipment in validated state through periodic review and scheduled requalification, aligned to site procedures and Annex 15 expectation and including data integrity (ALCOA, computerised system lifecycle principles)
• With echnical Operations and Quality, generate URS, generate, review and approve functional/technical specifications, Quality Risk Assessment, Traceability Matrix, IQ/OQ protocols and summary reports.
• Investigations & change: lead deviation/CAPA, conduct Quality Risk Management, author change requests, and manage validation impact assessments for changes
• Interface with audits: represent equipment and process validation in customer/regulatory inspections and defend strategy, execution and reports
• Collaborate across functions: work with QA, Analytical/QC, Engineering and Production to execute qualifications or PPQs to plan
• Broader validation: coordinate equipment/cleaning validation to ensure end‑to‑end compliance and data integrity across the lifecycle.

What you’ll bring

• Experience : Proven process validation experience in GMP drug product (OSD preferred), including PPQ leadership and CPV
• Regulatory knowledge : Practical application of FDA 2011 PV, EU GMP Annex 15, and ICH Q8/Q9/Q10.
• Statistics & tools : Competence with SPC/trending (e.g., Minitab/JMP) and strong technical writing for protocols and reports.
• Quality systems : Experience with eQMS (e.g., TrackWise,) 21 CFR Part 11/Anne 11 and ALCOA+ principles.
• Collaboration : Ability to work in and lead cross‑functional teams (e.g. Production, Formulation Development, Engineering), manage multiple PPQ workstreams, and meet committed timelines to plan.

Degree: in Life Science or Engineering, or equivalent

A fantastic salary and benefits package is available, including

• annual bonuses for all
• generous holiday allowance
• healthcare reimbursement scheme

and a rewarding role where the work you do will ultimately be contributing to the advancement of human health.

Closing date

Closing date for receipt of applications is Tuesday 3rd November 2026 at 5pm local time.