At a Glance
- Tasks: Lead sterility assurance and contamination control in aseptic manufacturing.
- Company: Ipsen Biopharm Ltd, a global biopharmaceutical company focused on transformative medicines.
- Benefits: Empowering workplace culture, career growth, and impactful work in healthcare.
- Other info: Join a diverse team committed to inclusion and making a positive impact.
- Why this job: Make a real difference in patients' lives through quality assurance in pharmaceuticals.
- Qualifications: Degree in Microbiology or related field; experience in sterile manufacturing required.
The predicted salary is between 63000 - 77000 £ per year.
- 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 https://www. ipsen. com/ and follow our latest news on Linked In and Instagram.
Job Description
Working Pattern: On‑site
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
- 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.
Company Culture and Inclusion
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.
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.
At Ipsen, each employee makes a real impact.
Our teams are passionate about what they do because they care about making a difference in patients’ lives.
We invest in our employees to support life‑changing projects that create positive impact for patients and society.
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QC Micro & Sterility Assurance employer: Ipsen
Ipsen in Wrexham is an excellent employer, offering a collaborative work culture that prioritises innovation and excellence. Employees benefit from a supportive environment with opportunities for professional growth, all while working in a state-of-the-art packing facility that operates on a convenient Monday to Friday schedule. Join us to be part of a team that values your expertise and contributions in mechanical engineering and vision systems.
StudySmarter Expert Advice🤫
We think this is how you could land QC Micro & Sterility Assurance
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Ipsen. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Ipsen.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Ipsen. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Ipsen is looking for. A tailored application can really make you stand out!
We think you need these skills to ace QC Micro & Sterility Assurance
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Ipsen!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Ipsen that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Ipsen!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Ipsen, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Ipsen
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Ipsen that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Ipsen’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
