Sterility Assurance Specialist

Csod; Burton upon Trent; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

25 days annual leave

Private medical

Pension scheme

Annual pay reviews

Life insurance

Job summary

Sciensus is a life sciences business dedicated to patient access, engagement, and insights in pharma services across the UK and Europe. We are seeking a Sterility Assurance Specialist to ensure sterility, regulatory compliance, and continuous improvement across our compounding operations.

You will lead environmental monitoring programmes, act as SME, investigate deviations, and collaborate across teams to safeguard patient safety and product quality.

Qualifications

• Degree in Microbiology (or equivalent).
• Proven experience in aseptic manufacturing or sterile environments.
• Strong background in environmental monitoring and sterility assurance programmes.
• Experience investigating deviations and quality incidents.
• GMP knowledge and regulatory standards in healthcare/pharmaceutical settings.
• Excellent data interpretation and problem-solving skills.
• Strong communication and collaboration abilities.

Responsibilities

• Lead and maintain sterility assurance and environmental monitoring programmes in line with GMP.
• Act as subject matter expert providing guidance across the business.
• Support and drive continuous improvement initiatives.
• Lead investigations (deviations, non-conformances, complaints) and act as technical approver.
• Interpret and trend microbiological and environmental monitoring data.
• Monitor and report quality metrics to support compliance and performance.
• Support validation activities, including microbiological methods and sanitisation processes.
• Manage external laboratory relationships.
• Develop and maintain quality documentation.
• Deliver microbiological and aseptic training and mentoring across teams.

Skills

Environmental monitoring

Aseptic manufacturing

Data interpretation

Problem solving

Independent worker

Education

Degree in Microbiology

Job description

Burton on Trent, Staffordshire, United Kingdom

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 quality mindset

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.
So, 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.

What we offer our people?

We work hard to make sure colleagues feel motivated, developed, and recognised for the great work they do.
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.

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. #togetherwewin