Computer System Validation Specialist (FTC) – Onsite
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
We are looking for a CSV Specialist to join our Quality department at Sartorius Stedim BioOutsource 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 arelooking 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.
Grow with us YourResponsibilities
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
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
Asa growing globallife 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 platformeven before joining
Welcoming Culture: Mutual supportteam-spirit and international collaboration; communities on numerous topics such as coaching agile working and businesswomennetwork
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
About Sartorius
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.
Experience:
IC
Key Skills
- Computer Science
- Active Directory
- Clearance
- Facility
- HVAC
- Linux
- Project Management
- Troubleshoot
- Desktop
- Control Systems
- Management System
- Setup
- hardware
- Data Analysis
- Technical Support
About Company
Sartorius offers solutions for the biopharmaceutical industry and laboratories, from drug discovery and development to production platforms for biomanufacturing.
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