Senior Validation Specialist – Manufacturing Support Location: Charnwood Campus, Loughborough, United Kingdom Hours: 37.5 hours per week Monday to Friday. Flexible working hours Business Unit: Almac Pharma Services Ref No.: HRJOB11293 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 Validation 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 Technical 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/Annex 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. Apply Now Please ensure your CV clearly outlines how you meet criteria for this role – refer to the job description attached to this advert for full details of the essential and desirable criteria required. Please upload your CV in PDF format where possible. 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 Sunday 8th March 2026 at 5pm local time.