Sterility Assurance Lead in Swindon

Job description

Sterility Assurance Lead

Swindon, UK | Full-Time | On-site |

Start Date: ASAP | Contract until 31/12/2025

Join a top-tier global leader in the pharmaceutical sector, renowned for innovation, quality, and excellence in healthcare solutions. We are seeking a highly experienced Sterility Assurance Lead to drive contamination control and sterility assurance strategies at our Swindon site.

Key Responsibilities

• Lead the Contamination Control Strategy and Sterility Assurance Program across the site, ensuring alignment with the latest regulatory standards and industry best practices.
• Oversee surveillance of operational activities to minimize environmental contamination and product risk.
• Collaborate cross-functionally to manage quality events impacting sterility, including deviations and microbiology-related complaints.
• Own and maintain microbiology risk assessments and sterilization-in-place protocols.
• Author and review SOPs related to sterility assurance; support change evaluations affecting product quality.
• Drive continuous improvement initiatives in collaboration with site teams to enhance sterility assurance levels.

Qualifications & Skills

• Master’s Degree in Microbiology.
• Minimum 5 years of experience in microbiology within the pharmaceutical industry.
• Deep understanding of GMPs, EU GMP Annex 1, and sterility assurance principles.
• Proven expertise in contamination control, process validation, and cleaning validation.
• Strong communication and stakeholder management skills.
• Ability to mentor junior staff and lead cross-functional meetings.
• Fluent in English

Work Environment & Culture

• Standard hours: Mon–Fri, 8:30–16:40 (no shifts, overtime only if requested).
• Collaborative and fast-paced environment with a strong focus on quality and compliance.

This is a unique opportunity to make a significant impact in a high-performing team at a leading pharmaceutical company. If you're passionate about sterility assurance and ready to take the next step in your career, we’d love to hear from you.

Extra information

Status

Open

Education Level

Secondary School

Location

Swindon

Type of Contract

Part-time jobs

Published at

29-10-2025

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English