QC Micro & Sterility Assurance

Title:

QC Micro & Sterility Assurance 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 endeavour 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  and follow our latest news on Linked In and Instagram.

Job Description:

Location:

Wrexham, North Wales

Working Pattern:
On‑site

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.

• 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.

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

• 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.

• Degree specialising in Microbiology.
• Extensive experience within…