We are looking for:
An enthusiastic and detailed orientated Computer System Validation (CSV) Specialist to support the technical administration of GMP informatics platforms and software for Hoddesdon Analytical and Process Chemistry laboratory employees.
At Pharmaron we offer:
1. Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
2. Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
3. A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!
Key Roles and Responsibilities:
4. Support R&D and QC laboratories as System Admin on 20+ systems.
5. Perform business critical roles as System Admin on Agilent OpenLab CDS and Revvity Signals (E3) ELN.
6. Lead validation activities for COTS systems.
7. Draft and review validation documentation (IA, URS, FS, IQ, OQ, PQ, QP, TRM, QSR, etc.).
8. Perform GMP Risk & Impact Assessments and Data Integrity Risk Assessments.
9. Support creation, modification and removal of user accounts.
10. Collaborate with IT and QA to manage system changes, upgrades, deviations and investigations within the QMS.
11. Conduct periodic reviews for active systems.
12. Support decommissioning activities for systems being retired from use.
13. Provide technical support for validated systems.
14. Maintain and update System Admin SOPs, configuration specs, and technical guides.
15. Responsible for the creation, revision of Administrative SOP's met with Data Integrity requirements and associated documents for the site-based Lab Systems.
16. Participate in internal audits and support external inspections.
17. Act as a liaison between business users and IT for system-related issues.
18. Contribute to continuous improvement initiatives within the CSV framework.
Requirements:
19. Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related field.
20. 2–5 years of CSV experience in the pharmaceutical or biotech industry.
21. Comprehensive understanding of software development lifecycle (SDLC).
22. Proven track record and understanding of SDLC documentation and regulatory compliance.
23. Understanding of QMS, GMP, ALCOA+ and Data Integrity principles.
24. Good understanding of laboratory systems, instruments, and associated software.
25. Strong record of accomplishment in validation of scientific software systems.
26. Strong knowledge of IT systems Client Server environment, Windows, Data communications equipment (Routers, Switches, LAN/WAN, Data Backup and Restore) would be desirable.
27. Some experience with coding (e.g. Python) would be desirable.
Our Company: “We are a dynamic, fast-growing company, with an enviable reputation for leading-edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.
We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.
Pharmaron acquired the Hoddesdon campus, consisting of several purpose-built scientific and administrative buildings together with a purpose-built conference area in February 2017. The research building has more than 5,000m2 of premier R&D space and houses an established Process Chemistry, Analytical Chemistry and Drug Discovery teams. In addition, a Formulation Development team was also recently established. The Hoddesdon site has state-of-the-art Good Manufacturing Practice (GMP) standard facilities for the development of Active Pharmaceutical Ingredients (API), Formulation Development (FD) and Process Chemistry (PC).
28. We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
29. We offer state of the art working environment on-site.
30. We offer the opportunity for growth and development and will support funding for relevant training and development programmes.
Why Should You Apply?
31. This is an opportunity for you as a CSV Specialist to make a real impact in a highly scientific and regulated environment and demonstrate leadership, ambition and the desire to grow with the department.
32. Build and shape your career in an environment that sets and commits to the highest standards.
33. To be part of a team who supports each other, embraces and solves technical challenges and put excellence at the heart of all that we do.