RoslinCT is a global CDMO focused on Advanced Cell and Gene Therapies.
It was established in 2006, built upon the ground-breaking cloning technology of Dolly the Sheep.
RoslinCT is one of the first to produce clinical-grade human pluripotent stem cells and developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.
Digital Lead - Environment Monitoring (12-Month Fixed Term Contract) Location: Edinburgh BioQuarter (Hybrid working options considered) 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.
Find out more about what we do here !
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 Digital Lead - Environmental Monitoring to join our team!
This position is a 12-month fixed-term contract.
You will be a key member of our Quality Control Microbiology team and hold responsibility for the design and delivery of a microbial EM digital system.
This role is well suited to an experienced cGMP microbiology professional with a strong interest in cGMP Digital Systems, preferably with a background in sterile aseptic drug product manufacturing facilities.
You will support various departments, including QC Microbiology, Manufacturing, Quality, and Training Academy.
In doing so, you will: Assess and improve current processes Design and build electronic microbial electronic records, logs and forms Drive change management and training in the new ways of working.
You will map current processes and data flows and help design the "to be" processes and recipe requirements/specifications.
Act as a system owner for the MODA EM, accountable for maintenance and change management.
Supporting of regulatory (FDA/MHRA etc) and client audits as an aseptic sterility assurance subject matter expert.
Partner with supplier developers to develop system training materials and support training during roll out.
About you: The ideal candidate for this role will be able to demonstrate the ability to influence others, work collaboratively and provide constructive challenge.
Experience in sterile aseptic processing and the associated regulations.
You will have experience in, or a desire to learn, business process mapping, basic coding skills, and computer system validation.
Experience of media fills/simulations, environmental monitoring, and personnel monitoring in Grade A – D environments.
You will have the ability to provide a logical/mathematical approach.
You will have exceptional organisational and planning skills.
You will demonstrate excellent communication and interpersonal skills and have a proven track record in negotiation.
Able to effectively manage stakeholders' and customer expectations.
A determination to continually develop and improve standards.
Qualifications A degree in Microbiology or science discipline.
A minimum 3 years' experience in a Sterile Biopharmaceutical Manufacturing Facility, preferably in a Cell & Gene Therapy or CDMO business.
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 detailing why you are interested and why we should hire you.
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 ****** .
We're here to assist and make things as smooth as possible for you.