Sterility Assurance Manager

Sciensus; Burton upon Trent; On-site; GBP 40,000 - 55,000; Full time

Benefits offered by this job

25 days annual leave plus bank holidays

Professional fees reimbursed

Yearly pay reviews

Life insurance

Private medical (subject to grade or service)

Job summary

Sciensus in Burton upon Trent is seeking a Sterility Assurance Specialist to ensure the highest standards of sterility and regulatory compliance in chemotherapy manufacturing. You will play a vital role in shaping quality systems, driving continuous improvement, and influencing best practices for patient safety.

The ideal candidate will have a degree in Microbiology and proven experience in sterile environments, with a collaborative mindset and a passion for quality. Our benefits include 25 days annual leave, professional development opportunities, and a comprehensive benefits package.

Qualifications

• Proven experience in aseptic manufacturing or sterile environments.
• Strong background in environmental monitoring and sterility assurance programmes.
• Knowledge of GMP and regulatory standards within a healthcare or pharmaceutical setting.

Responsibilities

• Leading and maintaining sterility assurance and environmental monitoring programmes.
• Providing guidance as a subject matter expert across the business.
• Leading investigations for deviations and acting as a technical approver.

Skills

Microbiology knowledge

Aseptic manufacturing experience

Environmental monitoring expertise

Data interpretation skills

Problem-solving

Communication skills

Education

Degree in Microbiology or equivalent experience

Job description

At Sciensus, we manufacture chemotherapy treatments that are directly used to treat our patients. As a Sterility Assurance Specialist, you’ll play a vital role in ensuring the highest standards of sterility and regulatory compliance across our compounding operations.

At the heart of this role is patient safety, where you will have the chance to shape and strengthen our quality systems, influence best practice, and drive continuous improvement.

What You’ll Be Doing

• Leading and maintaining robust sterility assurance and environmental monitoring programmes in line with GMP
• Acting as the subject matter expert providing guidance across the business
• Supporting and driving continuous improvement initiatives
• Leading and contributing to investigations (deviations, non-conformances, complaints) and acting as a technical approver
• Interpreting and trending microbiological and environmental monitoring data
• Monitoring and reporting quality metrics to support performance and compliance
• Supporting validation activities, including microbiological methods and sanitisation processes
• Managing external laboratory relationships
• Developing and maintaining quality documentation
• Delivering microbiological and aseptic training and mentoring colleagues across teams

Who We’re Looking For

• Degree in Microbiology (or equivalent experience)
• Proven experience in aseptic manufacturing or sterile environments
• Strong background in environmental monitoring and sterility assurance programmes
• Experience investigating out-of-limit results, deviations, and quality incidents
• Knowledge of GMP and regulatory standards within a healthcare or pharmaceutical setting
• Skilled in data interpretation, problem‑solving, and continuous improvement
• Confident working independently, with strong critical thinking and decision‑making skills
• Excellent communication and collaboration abilities, with a passion for quality

What’s In It For You

• Opportunity to make a real impact on patient safety and outcomes
• Being part of building a small micro‑lab and team
• Exposure to regulatory audits, inspections, and high‑quality standards
• A role where you can shape processes and influence best practice
• Ongoing opportunities for professional development and continuous improvement
• A collaborative environment that values expertise, innovation, and a quality mindset

What We Offer Our People

Additional to a competitive salary we can also offer a comprehensive benefits package, including:

• 25 days annual leave plus bank holidays
• Professional fees reimbursed
• Yearly pay reviews
• Annual company event
• Refer a friend scheme
• Contribution based pension scheme
• Life insurance
• Paid volunteer day
• Electric Car Scheme
• Extensive wellness initiatives
• Discount & cashback portal
• Private medical (subject to grade or service)
• Ongoing learning and development opportunities

Who We Are

Sciensus is a life sciences business specialising in patient access, engagement and insight solutions. We provide healthcare to patients with long‑term conditions, rare diseases and cancer. For 30 years, we’ve supported patients to access the life‑changing treatment they need, in the comfort and convenience of their own homes across the UK and Europe. Today, we combine our clinical experience from over 70 million patient interactions with the latest technology to help over 200,000 patients a year make the most of their medicine. Using unparalleled insights, we connect with people powerfully and personally, focusing on their unique needs, empowering them to achieve their goals, and supporting them every step of the way.

At Sciensus we are committed to developing and engaging a diverse workforce representative of the customers and communities we serve, to maintain our status as a leader in pharma services and deliver to the best possible health outcomes for patients.