An exciting opportunity for a CQV Engineer has arisen with our client a biopharma company based in Dublin. The CQV engineer will be part of a project team to procure, install and qualify new equipment and modify/upgrade equipment that is located in a sterile fill finish facility. Equipment will include upgrades to isolators, a new isolator, new autoclave sterile loads and new vessels. This role will include installation (IQ) and operational/functional (OQ) testing of equipment, along with Performance Qualification (PQ) (temperature mapping and use of biological indicators) to ensure that the systems meet user and regulatory requirements.
- Completing and managing the Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of equipment.
- Programming and installation of temperature and relative humidity loggers for mapping of units.
- Working with system owners to generate user requirements specifications (URS).
- Writing, review and approving protocols / test scripts to ensure they meet site, and regulatory requirements and procedures.
- Completion of test protocols, data analysis and generation of conclusions.
Reviewing project documentation such as installation completion certificates, drawings, equipment data books, equipment & piping test packs and vendor commissioning packs to ensure they meet URS requirements, and assembling the site documentation pack.
- Reviewing executed commissioning and qualification packs.
- Generating and managing events / deviations.
- Working with the operation unit to support maintaining autoclaves and isolators in a GMP state by revalidating (periodic temperature mapping) of the systems.
- Interface with the equipment technology team, customers, suppliers, project groups and QA, as required, in the delivery of projects.
- Successful project delivery will involve ensuring the new or modified systems are fit for use for the projected life cycle of the systems, including ensuring the systems are reliable and that future maintenance, revalidation and calibration works are cost effective and result in minimum system downtime.
- Working with project teams to analyse bids and determine the most appropriate system to purchase and install based on the ability of the system to meet user and site requirements, the use of best available technology, schedule, reliability, energy and environmental impact, life cycle, total cost of ownership including procurement, maintenance, calibration, CQV and revalidation costs.
- Generation of quality risk assessments and project / validation plans.
- Updating calibration and maintenance systems and spare parts lists.
- Execution of field CQV works utilising the necessary safe systems of work.
Ensuring engineering policies and procedures are adhered as applicable
Qualifications & Experience:
- Minimum qualification B.Sc./B.Eng or M.Sc./M.Eng Degree in Chemical, Mechanical or Building Services Engineering, Chemistry, Instrumentation or Biological Science.
- Five years plus experience qualifying GMP systems.
- Experience of temperature mapping and of using mapping equipment (eg KAYE, Lives) to qualify isolators, vessels and / or autoclaves.
- Understanding of commissioning, qualifying or verifying GMP systems.
- Understanding of PQ regulatory requirements.
- Experience of authoring test scripts / protocols, test data compilation with summary reports and statistical analysis of same.
- Excellent documentation practices.
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