Requalification Technician
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Job Summary
Work Schedule
Rotational M-F daysEnvironmental 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 heightsJob 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 lifecyclehelping biotech and biopharma companies bring treatments to patients with speed flexibility and quality.
About the Role
This position sits within Manufacturing Engineering / Validation and focuses on maintaining the validated state of sterile fill/finish processes and supporting systems.
Youll 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
If youre looking for a role where you can apply your technical expertise to maintain high standards in sterile manufacturing wed like to hear from you.
Competitive Package and Shift Allowance
Required Experience:
IC
Key Skills
About Company
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