Be at the heart of actionFly remote-controlled drones into enemy territory to gather vital information.

Apply Now

Sterility Assurance Lead

Stratton Saint Margaret
1 day ago
Create job alert

Elevate Quality: Sterility Assurance Lead - Join the Team in Swindon!

Are you a Master's-educated Microbiologist ready to step into a leadership role where your expertise directly safeguards product quality and patient safety? We are seeking a highly experienced and proactive Sterility Assurance Lead (Senior QA Sterility SME) to own and drive the Contamination Control and Sterility Assurance strategy across our entire Swindon facility.

This is a critical, hands-on role for an expert with at least 5 years of proven microbiology experience in the pharmaceutical industry, possessing deep practical knowledge of GMPs, EU GMP Annex 1, and the latest regulatory compliance.

The Opportunity: Own Sterility Assurance

As our Sterility Assurance Lead, you will be the site's authority, responsible for the integrity of our sterile manufacturing environment and products.

Key Responsibilities Include:

Strategy Ownership: Develop, implement, and maintain the site's Contamination Control Strategy and overall Sterility Assurance strategy, ensuring compliance with the most updated regulations and industry best practices.
Risk Management: Own and maintain the site Microbiology Risk Assessment and the Sterilization-in-Place concept.
Quality Event Management: Actively collaborate on the floor to manage quality events impacting sterility, providing expert microbiological input for deviations and complaints.
Continuous Improvement: Support the Environmental Monitoring (EM) review and drive action plans to continuously increase the Sterility Assurance Level across all processes and systems.
Documentation & Change: Write and/or review critical SOPs and evaluate changes with a potential impact on product quality.

What You Bring:

Education: Master's Degree in Microbiology.
Experience: Minimum 5 years in pharmaceutical industry microbiology, with extensive background in sterility assurance, process/cleaning validation concepts, and contamination control.
Expert Knowledge: A deep working understanding of GMP regulations and international guidelines, especially EU GMP Annex 1.
Leadership: Strong interpersonal and communication skills with the ability to coach and mentor junior employees and lead compliance/scientific discussions.
Availability: Participation in on-call services, remote, based on departmental needs.Work Details:

Location: Swindon, UK
Schedule: Full-time, Standard working hours (Mon-Fri) 8:30-16:40
Environment: Requires some degree of PPE (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)If you are ready to take full ownership of sterility assurance at a leading pharmaceutical site and drive regulatory excellence, apply today!

Interested? Please apply using the button below or call Danielle on (phone number removed) for an informal discussion.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business

Related Jobs

View all jobs

QC Team Leader - Microbiology

Microbiologist

Biostatistician

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Why Biotechnology Careers in the UK Are Becoming More Multidisciplinary

Biotechnology once meant pipettes, lab benches & research reports. But in today’s UK job market, biotech careers are no longer confined to wet labs or sequencing centres. As the sector expands into gene therapies, synthetic biology, personalised medicine, agricultural biotech, and bioinformatics, professionals are expected to integrate not just biology & chemistry, but also law, ethics, psychology, linguistics & design. This change reflects a broader truth: biotechnology doesn’t happen in isolation. It impacts people’s health, the environment, food supply & society at large. That means careers in biotech now require more than scientific knowledge — they demand legal awareness, ethical reasoning, patient empathy, clear communication, and user-centred design. In this article, we’ll explore why biotech careers in the UK are becoming multidisciplinary, how law, ethics, psychology, linguistics & design are shaping job descriptions, and what job-seekers & employers need to do to succeed in this transformed landscape.

Biotechnology Team Structures Explained: Who Does What in a Modern Biotechnology Department

Biotechnology is a fast-moving, highly interdisciplinary sector that spans research, development, clinical trials, manufacturing, regulatory affairs, and commercialisation. In the UK, biotech firms, pharmaceutical companies, academic spin-outs, and contract research organisations (CROs) are collaborating more than ever, leading to the creation of complex teams with specialised roles. To deliver safe, effective, and compliant biotech products — whether diagnostics, biologics, gene therapies, environmental biotech, or agricultural innovations — it's vital to know who does what. This article will map out the structure of a modern biotech department. We’ll define the key roles, how they interact across the product lifecycle, what skills are required in the UK, typical career paths, salary expectations, and examples of how startups versus large firms organise themselves. Whether you are a hiring manager or a job seeker, this will help you understand the landscape of biotechnology jobs in the UK.

Why the UK Could Be the World’s Next Biotechnology Jobs Hub

Biotechnology is one of the most transformative fields of the 21st century. From developing new medicines and diagnostics to advancing sustainable agriculture, biofuels, and industrial processes, biotechnology is at the heart of tackling some of the world’s biggest challenges. Countries worldwide are investing heavily in biotech innovation, seeking both economic advantage and solutions to pressing social issues. The United Kingdom is especially well placed to lead. With world-class universities, cutting-edge research institutes, a strong pharmaceutical sector, and growing clusters of innovative startups, the UK has all the ingredients to become the world’s next biotechnology jobs hub. For job seekers and employers alike, the opportunities are immense. This article explores why the UK could emerge as a global leader in biotechnology jobs, what makes the country so competitive, where the opportunities lie, and what challenges need to be addressed.