Work ScheduleRotational M-F days
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Working at heights
Description🔬
Process Requalification Technician – Sterile Fill/Finish📍 Swindon, UK | Full-time | Double-day shift (rotating early and late shifts)
Join a global Pharma Services organisation supporting the development and manufacture of life-saving therapies. As a leading CDMO, we work across the full drug lifecycle—helping biotech and biopharma companies bring treatments to patients with speed, flexibility, and quality.
About the RoleThis position sits within Manufacturing Engineering / Validation and focuses on maintaining the validated state of
sterile fill/finish processes and supporting systems.
You’ll be responsible for executing and managing
process requalification activities, ensuring continued compliance with EU Annex 1, GMP standards, and site contamination control strategies. Your work will directly support operational readiness and ongoing manufacturing performance.
Key Responsibilities- Execute requalification activities for aseptic manufacturing processes and cleanroom environments
- Manage the requalification lifecycle, including periodic and event-driven activities
- Plan and document activities in line with approved protocols, maintaining inspection readiness
- Requalify temperature-controlled systems (e.g. freezers, cold rooms, incubators)
- Assess the impact of changes, deviations, and maintenance on validated state
- Author and review protocols, reports, and risk assessments
- Support regulatory inspections and audits
About You- Degree or equivalent in engineering, pharmaceutical sciences, biotechnology, or similar
- Experience in validation, requalification, or process qualification within a GMP-regulated pharmaceutical or biotechnology manufacturing environment
- Background in sterile or aseptic manufacturing is strongly preferred
- Good understanding of cGMP, data integrity, and regulatory expectations
- Able to manage multiple activities with a structured, detail-oriented approach
- Comfortable working in a regulated environment with a focus on quality and compliance
Why Join- Work within a technically focused engineering and validation team
- Contribute to maintaining robust, compliant manufacturing processes
- Opportunity to support complex sterile manufacturing operations in a regulated setting
- Be part of a site continuing to grow its capabilities and capacity
Competitive Package and Shift Allowance
About Thermo Fisher ScientificThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
