Senior C&Q Engineers required by CareerWise Recruitment for our Cork based Biotech client. Initial 12 month contracts on offer. Please contact Diarmuid Buckley for full details.
Role of this position
- Commission and/or qualify site equipment systems such as skids, vessels, bio-reactors, temperature controlled units and utility systems (such as water, clean steam, HVAC, process gases)
- Provide input into all aspects of validation i.e. from design through to the commissioning and qualification execution phases
- Participate in the design of systems and equipment to ensure that they comply with GMP requirements. Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
- Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
- Execute qualification protocols as required.
- Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
- Prepare reports of executed protocols for review by QA.
- Initiate and implement change control activities in accordance with site procedures.
- Qualified Engineer, science graduate or equivalent.
- Experience on commissioning, qualifying / verifying some of the following systems: Utilities (water for injection, clean steam, process gases, HVAC), fridges, freezers, LAF, BSC units, autoclaves and isolators.
- Experience writing, reviewing and/or approving commissioning, Verification / qualification test documents and reports.
- Experience temperature mapping
- Experience with use of Delta V control systems /PIMs / KAYE Validator an advantage
Please call Diarmuid Buckley today for further information on 021- 4355432 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)