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

Job 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 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.

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 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