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 Bio Outsource Confidence Viral Clearance Quality this role you will be responsible for maintaining a harmonized 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. Its an onsite position located in Maxim Park Motherwell.

• On a daily basis you will 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 Confidence management

• 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.

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 business women network
• Health & Well-Being :
  Wide section of health and well‑being support such as healthcare plans and health assessment services
• Benefits

• Attractive Working Conditions
• 35 hours working week
• 29 days annual leave plus public holidays
• Annual option to buy sell or carry over annual leave
• Free parking on site
• Free hot and cold drinks
• Regular social events
• Health & Wellbeing
• Competitive benefits package including :
  Private Medical Insurance, Private Dental Insurance, Group Life Assurance, Travel Insurance (Employee Paid), Salary Sacrifice Health Assessment Service, Salary Sacrifice Cycle to Work Scheme, Planning Ahead For Your Future, Group Personal Pension Plan, Group Income Protection, Salary Sacrifice Will Writing Service

Sartorius is part of the solution in the fight against cancer dementia and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application.

IC

• Computer Science,Active…