Description
One of Quanta's leading global biotech clients are looking to add the skills of a CSV Engineer with experience in Delta V.This role will be working on-site via a third-party supplier conducting the generation and execution of CSV protocols around the Delta V system.
The successful candidate's responsibilities will include:
- 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.
- 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 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.