Work Schedule
Rotational M-F days
Environmental Conditions
Adherence 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
🔬 Process Requalification Technician – Sterile Fill/Finish
đź“Ť 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.
This 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
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
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
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
If you’re looking for a role where you can apply your technical expertise to maintain high standards in sterile manufacturing, we’d like to hear from you.
Competitive Package and Shift Allowance
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
