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. <...
Senior Technical Specialist – Manufacturing Validation in Loughborough employer: Almac Group (Uk)
Join a leading global biopharma company in Charnwood, Loughborough, where innovation meets opportunity. We offer a supportive work culture that values employee growth and development, alongside competitive salaries and benefits. With a focus on cutting-edge technology, you'll be part of a team that is dedicated to making a meaningful impact in the pharmaceutical industry.
