At a Glance
- Tasks: Supervise a team in Computer Systems Validation activities and ensure project milestones are met.
- Company: Join RoslinCT, a leader in cell and gene therapy innovation.
- Benefits: Generous salary, 31 days leave, private healthcare, and flexible benefits.
- Other info: Inclusive workplace with excellent growth opportunities and support for all applicants.
- Why this job: Make a real impact in life-changing therapies while developing your career.
- Qualifications: Experience in CSV within GMP environments and strong leadership skills.
The predicted salary is between 36000 - 44000 £ per year.
Location: Shawfair
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
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.
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 jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.
Computer Systems Validation (CSV) Supervisor I in Dalkeith employer: RoslinCT EU
At RoslinCT, we pride ourselves on being a world-leading cell and gene therapy organisation that not only transforms lives but also fosters a collaborative and inclusive work culture. As a Project Manager in Shawfair, you will enjoy a generous salary package, extensive annual leave, and comprehensive health benefits, all while working in a dynamic environment that encourages professional growth and development. Join us to be part of a team that values your contributions and supports your career aspirations in the cutting-edge field of biotechnology.
StudySmarter Expert Advice🤫
We think this is how you could land Computer Systems Validation (CSV) Supervisor I in Dalkeith
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We think you need these skills to ace Computer Systems Validation (CSV) Supervisor I in Dalkeith
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at RoslinCT EU!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show RoslinCT EU that you're not just a fit for the job but also a safety-conscious candidate!
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How to prepare for a job interview at RoslinCT EU
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at RoslinCT EU that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
