Sterility Assurance Specialist

Sciensus; Burton upon Trent; On-site; GBP 40,000 - 60,000; Full time

Job summary

A life sciences solutions partner in the UK is seeking a Sterility Assurance Specialist. The successful candidate will ensure effective sterility assurance and environmental monitoring while leading investigations into product deviations. Ideal candidates have at least 3 years of experience, particularly in microbiology and aseptic environments. This role offers a competitive salary and a comprehensive benefits package including 25 days of annual leave and private medical coverage.

Benefits

Competitive salary

25 days annual leave plus bank holidays

Yearly pay reviews

Contribution based pension scheme

Life assurance

Employee benefits platform

Private medical after qualifying period

Ongoing learning and development opportunities

Onsite gym

Canteen

Prayer room

Quiet room

Qualifications

• Minimum 3 years implementing environmental control programs and OOL investigations.
• Preferred: 5 years microbiology experience in an aseptic facility.
• Strong operational experience in aseptic manufacturing.

Responsibilities

• Ensure effective sterility assurance and environmental monitoring programmes.
• Lead investigations into product/process deviations and customer complaints.
• Track and report quality metrics for internal and external use.

Skills

Environmental control programs

Microbiology experience

Aseptic technique

Quality improvement tools

Lean manufacturing

Education

Degree in Microbiology

Job description

What You’ll Do at Sciensus as a Sterility Assurance Specialist

• Ensure effective sterility assurance and environmental monitoring programmes in compliance with GMP.
• Support sterility assurance practices and identify new technologies for microbiological testing and environmental control.
• Lead investigations into product/process deviations and customer complaints.
• Provide expert guidance on sterility assurance, including risk reduction initiatives.
• Interpret and trend microbial identification and environmental monitoring data, setting appropriate alert limits.
• Track and report quality metrics for internal and external use.
• Validate microbiological methods and sanitization processes.
• Oversee external laboratory service levels and audits.
• Develop and maintain quality documentation, including SOPs.
• Deliver microbiological and aseptic operator training for staff.

What We’re Looking For

Experience

• Minimum 3 years implementing environmental control programs and OOL investigations.
• Preferred: 5 years microbiology experience in an aseptic facility.
• Strong operational experience in aseptic manufacturing and aseptic technique.
• Skilled in quality improvement tools (FMEA, DMAIC, Process Mapping) and Lean manufacturing.
• Experience with change control and validation of microbiological methods.

Education

• Degree in Microbiology (or equivalent experience).

Who we are?

Sciensus is a proven life sciences solutions partner with more than 30 years’ experience navigating and unlocking the complex European healthcare ecosystem. We maximise patient access to medicines, accelerate product launches and drive long-term commercial success for our partners. Through a skilled team of over 500 licensed clinical staff and 1,650 colleagues globally, we work at the intersection of clinical excellence, patient experience and healthcare innovation. We support patients living with cancer, chronic conditions and rare diseases ‒ helping them access the life‑changing treatments they need, wherever they are.

What do we offer our people?

• Competitive salary and a comprehensive benefits package.
• 25 days annual leave plus bank holidays.
• Yearly pay reviews.
• Contribution based pension scheme.
• Life assurance.
• Employee benefits platform (retailer discounts and much more).
• Private medical (after qualifying period).
• Ongoing learning and development opportunities.
• Annual company event.
• Onsite gym, canteen, prayer room, and quiet room in the Burton Upon Trent office.

Our Values

We are a Disability Confident Committed Employer and have successfully gained the National Equality Standard (NES), the UK’s leading Equity, Diversity and Inclusion standard. We are committed to the fair treatment of all candidates, regardless of race, gender, religion, sexual orientation, age or disability. We welcome applications from all and select candidates based on skills, qualifications, and experience. Please discuss any reasonable adjustments you may require during the application process.

We are committed to achieving Net Zero and reducing our ecological footprint. We continually work on new initiatives, such as striving for Level 2 in the Greener Pharmacy Toolkit and replacing many of our vans with lower CO2 emission models. For more information on our sustainability efforts, please visit our corporate website.