Description
Our pharmaceutical client is looking for a CSV Engineer to support them in their manufacturing facility in the South East of the UK.Role and Responsibilities:
- The role would require completion of 21 CFR 11 assessments on Siemens S7 and bespoke systems, creation/review/execution of IQ/OQ documentation, creation of SOPs.
- Participate in GMP Risk Assessments and FMEA's, compliance review of Risk Assessment documentation.
- Ensure equipment changes are implemented as per change control procedures.
- Project co-ordination & communication of validation issues to team members & management.
- Maintaining an up-to-date knowledge of EMA and FDA regulatory requirements.
- Degree in Engineering/Science Discipline.
- Experience in computer system validation, essential.
- Experience of Siemens S7, SCADA, starter and equipment systems, essential
- Good working knowledge of Regulations and Guidelines, GAMP 5 requirements and ISPE Guidelines.
- Experience in the Pharmaceutical industry.
- Ability to participate in cross functional teams.