Sterility Assurance Specialist – Quality Control Microbiology

Location: Edinburgh BioQuarter

Who are we? We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives. Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Why join us? The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career. A generous salary package – we reward our people at the level they deserve. 31 days of annual leave, plus 4 public holidays which increases with tenure. A competitive company pension scheme to help you save for the future. Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind. Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us. Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your new role: We are looking for a Sterility Assurance Specialist to join our team! You will be a key member of our Quality Control Microbiology team and hold responsibility for enhancing our sterility assurance programme, ensuring it meets all aspects of international aseptic processing requirements. Responsibilities include:

• Conduct procedural reviews to assure best industry practice in respect to material handling and transfer, operator training, cleaning and aseptic practices, aseptic process simulations, filter integrity testing, cleanroom behaviours, environmental monitoring and microbial control.
• Provide expertise to the sterility assurance programme.
• Support the design, review and update of contamination control strategies.
• Application of quality risk management principles to evaluate and control all aspects of the sterility assurance of products and processes.
• Management and monitoring of the cleaning and disinfection programme.
• Providing advice and guidance on environmental monitoring and sterility assurance related investigations and CAPAs.
• Vigilant continuous review of regulatory awareness of changes impacting sterility assurance to ensure compliance.
• Supporting of regulatory (FDA/MHRA etc) and client audits as an aseptic sterility assurance subject matter expert.
• Development of a comprehensive knowledge-based sterility training programme encompassing both aseptic procedures and cleanroom behaviours including new start training, training resources, refresher training and knowledge checks and a coaching programme.
• Ability to work within graded cleanroom environments, adhering to local personnel gowning & cleanroom behaviour SOP’s/training.

About you: Strong knowledge of cGMP microbiology and sterility testing, media fills/simulations, environmental monitoring, cleanroom qualification/management and contamination control strategies. Sterile Biopharmaceutical Manufacturing Facility experience is required. Experience of Environmental Monitoring of GMP clean rooms. Experience in sterile aseptic processing and the associated regulations. An excellent understanding and proven background of working effectively in a GMP QC Microbiology department. Exceptional organisational and planning skills with the ability to plan whilst delivering results to deadline. Experience in cell culture and cell and gene therapy would be desirable, although not essential. Excellent communication and interpersonal skills. Able to effectively manage and influence stakeholders’ and customer expectations. Excellent administration and record keeping skills. Excellent attention to detail with a desire to continually develop and improve our processes. A determination to continually develop and improve standards.

Qualifications: A degree in Microbiology or equivalent qualification is required. A post-graduate qualification is desirable, although not essential.

Next Steps: If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form. At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners. We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms. If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.