Senior Technical Specialist – Manufacturing Validation Loughborough, UK Full time, Permanent Who We Are Almac Group is a global leader in advancing human health. We provide a range of expert services across the drug development lifecycle to pharmaceutical and biotech companies, supporting them in finding treatments for patients. Skills and attributes cGMP manufacturing CAPA Management System Validation PPQ 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
Senior Technical Specialist – Manufacturing Validation employer: Almac Group
Almac Group is an exceptional employer located in Craigavon, offering a dynamic work culture that fosters innovation and collaboration within the Pharma and Healthcare sectors. Employees benefit from comprehensive professional development opportunities, a commitment to employee well-being, and the chance to make a meaningful impact on healthcare solutions. Join us to be part of a forward-thinking team dedicated to continuous improvement and excellence in digital solutions.
