Computer System Validation Specialist (FTC) – Onsite

Join our Confidence Viral Clearance Quality Team as a Computer System Validation Specialist at our Maxim Park site. We are looking for a CSV Specialist to join our Quality department at Sartorius Stedim BioOutsource – Confidence Viral Clearance Quality Team. In this role, you will be responsible for maintaining a harmonised validation policy, ensuring computer systems are compliant with current regulatory standards, supporting implementation of chromatography systems and eQMS for our site in Maxim Park near Glasgow and our site in Marlborough in the US. The team consists of 4 professionals, and we are looking forward to shaping the future with you. This position is available full time for a fixed term period until the end of December 2026. It’s an onsite position, located in Maxim Park, Motherwell.

Grow With Us – Your Responsibilities

• Maintain computer system validation policy, ensure alignment with current regulatory standards (e.g.: 21 CFR Part 11, OECD 17, OECD 17 supplement, EU – GMP Annex 11, GAMP 5) for Confidence Validation Services.
• Maintain and update electronic systems, ensuring optimal performance and compliance.
• Conduct risk assessments, compile compliance reports, manage deviations, and ensure all documentation meets quality and regulatory standards.
• Create and oversee CSV protocols, including IQ, OQ, and PQ, ensuring thorough validation of electronic systems.
• Support periodic review of existing systems.
• Oversee the document lifecycle, from creation and revision to storage.
• Support administration of electronic systems ensuring efficient operation.
• Train team members to enhance team capabilities and ensure compliance.
• Collaborate with all stakeholders to guarantee systems comply with project and regulatory standards.
• Participate in regular project meetings to align with system owners and management, ensuring project requirements are met and issues are resolved.
• Supervise vendor interactions, including reviewing and tracking vendor deliverables and system qualifications.
• Collaborate with global/regional site quality units and functions to ensure harmonised practices.
• Any ad hoc duties to collaborate and contribute to other activities as identified.

What Will Convince Us

• BSc or MSc in Computer Science, Life Sciences or Engineering.
• Previous experience in a GLP or GXP environment with validating computer systems, however candidates from a quality or other validation expertise would also be considered i.e.: process, equipment or cleaning validation.
• Good understanding of laboratory systems, instruments and associated software.
• Good knowledge of QMS and eQMS.
• Knowledge of CSV regulatory standards (eg.: OECD 17, OECD 17 supplement, 21 CFR Part 11, EU – GMP Annex 11, GAMP 5) would be beneficial.
• Strong documentation skills and attention to detail.
• Good communication and written skills and the ability to interact with other departments.
• Ability to develop realistic work plans, set personal goals that align with company goals.
• Excellent skills in Microsoft packages such as Word, Excel.
• Good organisational skills with the ability to multi-task, prioritise and manage own workload.

In order to commence working with us, the successful candidate must have the right to work in the UK.

What We Offer

As a growing global life science company, stock listed on the German TecDAX, Sartorius offers a wide range of benefits: Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings. Making an impact right from the start: Comprehensive onboarding, including a virtual online platform – even before joining. Welcoming Culture: Mutual support, team-spirit and international collaboration; communities on numerous topics such as coaching, agile working and businesswomen network.