Sterility Assurance Expert

Title:

Sterility Assurance Expert

Company:

Ipsen Biopharm Ltd

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Sterility Assurance Expert

Location: Wrexham, North Wales

Working Pattern: On-site

Function: Quality / Technical Operations

About the Role

We are seeking an experienced Sterility Assurance Expert to play a critical role in safeguarding the sterility and quality of aseptically manufactured pharmaceutical products. This is an exciting opportunity for a microbiology and contamination control specialist to influence site strategy, lead complex investigations, and ensure compliance with global regulatory expectations.

Working within Technical Operations, you will act as the subject matter expert for sterility assurance, providing leadership across contamination control, aseptic processing, microbiological risk management, and regulatory compliance.

What You'll Be Doing

As our Sterility Assurance Expert, you will:

• Lead sterility assurance and contamination control activities across aseptic manufacturing operations.
• Develop, maintain and continuously improve the site's Contamination Control Strategy in line with EU GMP Annex 1 and international regulatory expectations.
• Perform and lead risk assessments relating to aseptic processing, cleanroom operations, isolator systems and critical interventions.
• Design and oversee environmental monitoring programmes, including trend analysis and investigation of excursions.
• Lead investigations into sterility failures, bioburden excursions, environmental monitoring out-of-specification results and contamination events.
• Drive scientifically robust root cause analysis and implementation of effective CAPAs.
• Provide microbiological expertise for cleanroom qualification, sterilisation processes, filtration systems, disinfectant qualification and aseptic process simulations (media fills).
• Support process validation and continuous improvement initiatives across manufacturing operations.
• Collaborate closely with Quality Assurance, Manufacturing, Engineering and Validation teams to embed sterility assurance principles into processes and facility design.
• Author, review and approve GMP documentation, including SOPs, protocols, reports and technical assessments.
• Support regulatory inspections and customer audits as the site expert for sterility assurance.
• Coach, mentor and develop colleagues in aseptic technique, contamination control and microbiological best practice.

About You

You'll be a scientifically minded professional with strong experience in sterile pharmaceutical manufacturing and a passion for contamination prevention and quality excellence.

Essential Requirements

• Degree in Microbiology, Life Sciences or a related scientific discipline.
• Significant experience within aseptic or sterile pharmaceutical manufacturing.
• Strong hands-on knowledge of sterility assurance and contamination control principles.
• Experience leading microbiological investigations and conducting risk assessments.
• Understanding of GMP regulations and industry standards, including EU GMP, Annex 1, FDA and PIC/S requirements.
• Experience interpreting microbiological, environmental monitoring and trend data.
• Excellent technical writing, communication and stakeholder management skills.
• Ability to influence cross-functional teams and drive quality-focused decision making.

Desirable

• Degree specialising in Microbiology.
• Extensive experience within sterile manufacturing environments.
• Experience supporting regulatory inspections and audits.
• Expertise in cleanroom design, qualification and contamination control systems.
• Experience with media fills, sterilisation validation and microbiological testing methodologies.

What Success Looks Like

You will be the recognised sterility assurance expert on site, ensuring the highest standards of microbiological control, regulatory compliance and product quality. Through your technical leadership, you'll help maintain inspection readiness, strengthen contamination control strategies and contribute to the safe supply of medicines to patients.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.