Description
A fantastic contract opportunity has arisen for an experienced VALIDATION ENGINEER to work at aworld leading Pharmaceutical plant on a large remediation project, to bring the project back on track.
Working within a STERILE FILL/FINISH manufacturing environment, we are looking for a number of VALIDATION ENGINEERS to work on the remediation programme and carry out the validation execution to equiment within a sterile /fill finish equpment such as: Autoclaves, Depyrogenation, Capping, VHP's, lyophisers etc
Responsibilities:
Carry out the validation activities within an aseptic/sterile environment, taking responsibility for creating specific equipment validation strategies. Undertake validation exercises on Autoclaves, Lyophilisation units, fillers, cappers and solution preparation within a sterile/aseptic pharmaceutical environment. Review/produce supporting validation documentation, as required, as part of a validation exercise. (IQ/OQ/PQ) Write and review validation protocols and reports for new and existing equipment.
Requirements:
- Degree qualified in Engineering based subject or related experience in a Validation/Qualification role.
- Experience within Sterile/Aseptic pharmaceutical Manufacturing environments with an understanding of equipment to include Autoclaves, Lyophilisation units, cappers, fillers, solution preparation.
- Solid experience of project lifecycle validation activities to include the qualification of equipment in conjunction with Project engineering/CAPEX teams.
- Demonstrable experience in drafting, executing and reporting of validation documentation ie. IQ, OQ, PQ protocols.
- Experience of working alongside regulatory auditors, liaising with FDA and/or MHRA investigators during audits. Fill/Finish.
Beautiful location! 6 month contract with a likely extension. All inclusive hourly rate required €
Desired Skills and Experience
- Validation execution
- Creation of documentation IQ OQ PQ
- Equipment experience - Autoclaves, CAPPING, depyrogenation, VHP's, lyophilisation
- Sterile OR Aseptic experience