Description
Contract Length: Initial 12 month contract, work until 2018Exciting opportunity for a CSV Engineer to support the existing lab facility of a global biotech organisation based near Dublin, for a 12 month contract. The Validation Engineer will be responsible for the completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
Role and Responsibilities:
- The role would require completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
- Projects will include supporting the qualification of plant computer systems such as Delta V, new plant equipment and also up-grades to existing computer systems and equipment.
- Quality review and approval of Equipment Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols.
- 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.
- Equipment to include: HPLC, GC, Washers, Plates etc...
- Degree in Engineering/Science Discipline.
- Experience in computer system validation essential.
- Labs systems experience 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.