Computer Systems Validation (CSV) Supervisor I

• An exciting opportunity for a Computer Systems Validation (CSV) Supervisor I to join our Validation team.
• You’ll be responsible for supervising a small team undertaking CSV activities for the business including facilities management software and equipment software.
• Monitoring key milestones within CSV projects, ensuring the availability of documented evidence at each milestone.
• Completing, reviewing and approving quality related documentation including but not limited to validation documents, change controls, deviations and risk assessments in accordance with GMP and standard operating procedures.
• Preparing, reviewing, approving and executing of CSV documentation (e.g. plans, protocols, reports, periodic reviews)
• Contributing to the set up and execution of the validation schedule for any new facility, when required.
• Communicating procedures and CSV outcomes with clients, when required.
• Providing subject matter expertise to all areas of the business, particularly in audits.

• Proven experience in Computer System Validation within a GMP regulated environment.
• A background in supervising, influencing or leading teams.
• Exceptional attention to detail, with a determination to continually develop and improve standards.
• Demonstrable experience of project-based work, including activities such as regulatory audits, GAP analysis, risk assessments and Data Integrity Assessments.
• Flexibility and adaptability to react to rapid changes in project priorities.
• Strong communication skills, particularly around communicating with customers and service providers.
• Proficient IT skills, particularly with Microsoft Word & Excel., * A degree in Life Sciences or Computer Science related subject, or equivalent training and experience.

• 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.

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.