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
Computer Systems Validation (CSV) Specialist
to join our team! This position will be a key member of our Quality Assurance team and will act as the subject matter expert for CSV projects. Monitor key milestones ensuring the availability of documented evidence. Provide CSV support to all areas of the business on a day-to-day basis, including guidance on best practices for the qualification and validation of systems to GMP. Support the continual development of Data Integrity within the QMS. Actively participate in Data Integrity assessments across the site, providing CSV input. Ensure IT systems, products, and services are delivered, installed, validated and maintained throughout their lifecycle to ensure compliance with regulatory requirements and best practice. Provide CSV support to all areas of the business including operation and retirement of suitable qualified/validated computer systems in accordance with current GXPs and SOPs. Create and support the implementation of governance of company policies relating to computer systems. Perform quality audits for prospective automated equipment and applications vendors to determine compliance with CSV processed, as required. Conduct periodic evaluation of computer systems to confirm that they remain in a valid state and are compliant with GMP. Participate in testing phases of projects as required. Review and delivery of training for CSV and compliance training at various levels across the business. Maintain an up-to-date knowledge of international regulatory requirements for CSV. About you Experience in GMP regulations in relation to Computer Systems Validation. Experience in project-based work, including activities such as regulatory audits, GAP analyses, and risk assessments. Use of electronic validation software system (e.g. ValGenesis) is desirable. Excellent organisational and planning skills with the ability to plan whilst delivering results to deadline. Excellent communication and interpersonal skills and a proven track record in negotiation whilst maintaining effective relationships. Excellent attention to detail, proven problem solver, self-motivate and positive with the ability to thrive in a fast-paced environment. Qualifications You will hold a degree in a Life Science or Computer Science subject or equivalent relevant 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.
#J-18808-Ljbffr
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
Computer Systems Validation (CSV) Specialist
to join our team! This position will be a key member of our Quality Assurance team and will act as the subject matter expert for CSV projects. Monitor key milestones ensuring the availability of documented evidence. Provide CSV support to all areas of the business on a day-to-day basis, including guidance on best practices for the qualification and validation of systems to GMP. Support the continual development of Data Integrity within the QMS. Actively participate in Data Integrity assessments across the site, providing CSV input. Ensure IT systems, products, and services are delivered, installed, validated and maintained throughout their lifecycle to ensure compliance with regulatory requirements and best practice. Provide CSV support to all areas of the business including operation and retirement of suitable qualified/validated computer systems in accordance with current GXPs and SOPs. Create and support the implementation of governance of company policies relating to computer systems. Perform quality audits for prospective automated equipment and applications vendors to determine compliance with CSV processed, as required. Conduct periodic evaluation of computer systems to confirm that they remain in a valid state and are compliant with GMP. Participate in testing phases of projects as required. Review and delivery of training for CSV and compliance training at various levels across the business. Maintain an up-to-date knowledge of international regulatory requirements for CSV. About you Experience in GMP regulations in relation to Computer Systems Validation. Experience in project-based work, including activities such as regulatory audits, GAP analyses, and risk assessments. Use of electronic validation software system (e.g. ValGenesis) is desirable. Excellent organisational and planning skills with the ability to plan whilst delivering results to deadline. Excellent communication and interpersonal skills and a proven track record in negotiation whilst maintaining effective relationships. Excellent attention to detail, proven problem solver, self-motivate and positive with the ability to thrive in a fast-paced environment. Qualifications You will hold a degree in a Life Science or Computer Science subject or equivalent relevant 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.
#J-18808-Ljbffr
