Requalification Technician

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 ? 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 Role 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.,

• 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
  
  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
  
  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