We are looking for a driven individual to join us as a Sterility Assurance Specialist.

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 at the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

As part of our continued growth, we are now recruiting across all of our teams including this brand-new Sterility Assurance Specialist role. This role is well suited to an experienced cGMP microbiology professional with a strong background in sterile aseptic processing.

The Role:
You will be a key member of our Quality Control Microbiology team and hold responsibility for overseeing and enhancing our sterility assurance programme, ensuring it meets all aspects of international aseptic processing requirements. The ideal candidate will hold experience in cGMP microbiology and sterility testing, sterile aseptic processing and biologics Manufacturing.

Responsibilities:
Work at RoslinCT is fast paced, and no two days are the same. Your responsibilities will therefore be varied, but will include;
* Procedural review 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.
* Providing oversight and expertise to the sterility assurance programme.
* Leading 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.
* Review of changes impacting sterility assurance.
* Supporting of regulatory and client audits as the 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.

​Qualifications:
You will hold a HND, HNC or BSc in a Life Science discipline or equivalent relevant experience.

Skills and Experience:
You will be able to demonstrate:
* Strong knowledge of cGMP microbiology and sterility testing, media fills/simulations, environmental monitoring, cleanroom qualification/management and microbiological control strategies.
* Experience in sterile aseptic processing and the associated regulations.
* Experience in cell culture and cell and gene therapy would be desirable, although not essential.

Benefits:
In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we offer:
​* 31 days of annual leave, plus 4 public holidays - when you have been with us for three years, we will give you an extra day holiday and when you reach 5 years, you’ll get an extra two days’ holiday.
* Competitive company pension scheme – we contribute up to 8% of your salary (depending on length of service) to ensure that you are all set for the future.
* Group Life Cover – you are automatically covered for three times your basic salary to give you peace of mind for you and your family.
* Healthcare Cashback, Mental Health/Wellbeing support and gym discounts via our Healthcare plan.
* Staff discounts on food, drink, electronics, entertainment and electricals.
* Access to our Cycle2Work Scheme so you can save up to 42% on a new bike to help with your commute and wellbeing.
* We have a dedicated Social Committee and other regular company events such as BBQs, team drinks, quizzes, parties and 5-aside football.
* Career Progression & Training Opportunities are provided for all of our staff to help you achieve your goals and grow professionally and personally.

Values:
A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. As such, you should be able to demonstrate:
* Passion for customer satisfaction.
* Ability to support a ‘one team’ approach.
* Great communication.
* Commitment to personal growth and development.
* Accountability for your work.

Location:
We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary.

Employer Value Proposition:
RoslinCT is seeking the best, brightest, and most passionate cell and gene therapy talent with a diverse range of skillsets, experience, and perspectives. We offer industry-leading annual leave allowances, career development opportunities and employee benefits, as well as working groups and social activities, and are dedicated to developing the next generation of experts and future leaders of our company. If you want to utilise your skills and talent in a state-of-the art company that truly changes lives, you belong at RoslinCT.