Computer Systems Validation Specialist
1 month ago
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job SummaryWe are currently recruiting for an Associate Application Specialist to work in the Computer System Validation team (CSV), based at our world class facility in Tranent, East Lothian.
The Computer System Validation (CSV) team support the departments conducting scientific studies by managing their computer systems (instrumentation/equipment and software) to meet regulatory requirements. This involves working collaboratively with scientific staff, IT and quality assurance to ensure strict regulatory expectations are met regarding the capture, processing and secure storage of electronic data, whilst providing a practical and user friendly system for scientific staff to conduct their work efficiently, effectively and with full trust and confidence in the data they produce.
The successful candidate’s role will be to help maintain current active computer systems, through implementing user access control requirements, troubleshooting reported errors, liaising with vendors, etc. They will also ensure systems remain relevant and fully compliant through regular reviews. Completion and administration of documentation is an active part of the regular duties. The successful candidate will be expected to keep modernising and improving the compliance and usability of systems through introduction of new features in a controlled manner involving software/instrument testing.
The minimum requirements for this role are:
- Ideally educated to a graduate level, preferably in a Scientific or Information Technology discipline but not essential.
- Candidates must be enthusiastic, proactive, organised, customer focused and have an analytical approach to problem solving.
- Experience of working in a regulated environment (GLP/GMP) preferred but not essential.
- Excellent communication skills and working seamlessly with different groups of people.
- Excellent computer system skills. (Excel, Word, etc.)
- Project Management skills and attention to detail
The salary for this role is £27,163 per annum, however consideration will be given depending on skills and experience.
Profile and Requirements
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.
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