Description
Main responsibilities- The purpose of the position is to provide review of validation documentation to ensure compliance with cGMP, GAMP 5, Corporate Directives, FDA and EMA Regulations and ICH and PIC Guidelines
- Working within a new biologics facility the CSV Engineer will be responsible for qualification of instrumentation and software for a laboratory group
Role and Responsibilities:
- Write and review of Computer System Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols
- Projects will include the qualification of plant computer systems such as Delta V, new plant equipment and also up-grades to existing computer systems and equipment
- 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
- Delta V DCS background/experience essential
- Experience in computer system validation essential
- Good working knowledge of Regulations and Guidelines, GAMP 5 requirements and ISPE Guidelines
- Experience in the Pharmaceutical/Biotechnology industry
- Ability to participate in cross functional teams