Senior Technical Specialist – Manufacturing Validation

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

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

Recruitment Agencies Please Note

Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CVs received or submitted directly to Hiring Managers will be considered unsolicited, and no fee will be payable. Thank you for your cooperation.

Closing Date

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