CSV Senior Engineer
Hyper Recruitment Solutions are currently looking for a CSV Senior Engineer to join a leading company based in the Middlesbrough area. As the CSV Senior Engineer you will be responsible for all computerised systems used to support GMP manufacturing
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CSV Senior Engineer will be varied however the key duties and responsibilities are as followed:
1. You will prepare and review all levels of validation documents and ensure that computerised systems are appropriately validated, e.g. Validation Strategy Plans, (DQ/IQ/OQ/PQ/FATS/SATS/URS), change controls
2. You will provide training on Computerised System Policies, SOPS, industry regulations trends and hot topics to project team, members, system owners and users.
3. You will provide CSV technical sign-off for all related documents and protocols.
4. You will audits as a CSV subject matter expert for suppliers of computerised systems or external service providers.
To be successful in your application to this exciting opportunity as the CSV Engineer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Software or related Engineering discipline and experience working in a biotechnology environment as a CSV Engineer or similar.
2. Proven industry experience of GAMP, risk based approach to validation and a good understanding of electronic records and signatures.
3. A working knowledge and practical experience with Traceability Matrices, Risk Analysis, electronic data security and e-data management.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.
This job was originally posted as www.jobsite.co.uk/job/959505304