Computer Systems Validation (Csv) Supervisor I

Roslinct Eu; Dalkeith; On-site; GBP 42,000 - 52,000; Full time

Benefits offered by this job

Private healthcare

Cycle2Work

Pension scheme

Life cover

Flexible benefits

Job summary

RoslinCT in the United Kingdom is seeking a Computer Systems Validation (CSV) Supervisor I to join the Validation team. You’ll supervise a small team carrying out CSV activities across facilities management software and equipment software.

You will monitor milestones, ensure documented evidence, and prepare and approve validation documents in line with GMP and SOPs. Strong communication and project-based experience are essential.

Qualifications

• Proven experience in Computer System Validation within a GMP environment.
• Experience supervising or leading teams.
• Experience with regulatory audits, GAP analysis, risk assessments and Data Integrity Assessments.

Responsibilities

• Supervise CSV activities for facilities management software and equipment software.
• Track milestones and ensure documentation at each stage.
• Prepare, review and approve CSV documents such as plans, protocols and reports.
• Coordinate validation schedule for new facilities when required.
• Communicate CSV outcomes with clients and support audits.

Skills

Team leadership

Collaborative work

Project coordination

Education

Life Sciences or Computer Science degree

Tools

Microsoft Word

Microsoft Excel

Job description

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.

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

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.

About you

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.

Qualifications

A degree in Life Sciences or Computer Science related subject, or equivalent training and experience.

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 [e-mail]. We’re here to assist and make things as smooth as possible for you.