- An exciting new opportunity has arisen for a Utilities CQV Engineer to join our client’s busy biopharmaceutical facility based in Co. Dublin.
- Your role will be to implement the commissioning and qualification of new/modified clean utilities and non GMP utilities and controlled environmental devices sitewide.
- The successful candidate will provide technical expertise to ensure that systems and equipment are installed, commissioned and qualified to the company’s and regulatory specifications.
Core Duties and Responsibilities:
- Generate documentation for cGMP commissioning/qualification of systems and equipment, including CTP/IQ/OQ/PQ protocols and reports.
- Raise and implement system change controls and ECM’s.
- Participate in design review for new/ modified utility systems.
- Participate in construction system mechanical completion walk downs.
- Perform execution of CTPs, IQ, OQ, PQ Protocols in field.
- Perform execution of temperature mapping of equipment.
- Perform pre- and post-study calibration verifications.
- Operate according to SOPs developed for validation, validated manufacturing operations and cGMP compliance.
- Develop and implement changes required to resolve deviations/ events effectively.
Minimum Qualifications and Experience:
- Sc/B.Eng. degree in engineering discipline, with particular emphasis on mechanical or process engineering.
- Minimum of 3-5 years’ experience from biotechnology or pharmaceutical GMP manufacturing environment.
- Experience in temperature mapping with lives xpertval system is an advantage.
- Experience with qualification of clean utilities and HVAC.
- Demonstrated ability to work on own initiative and proactively respond to business needs.
- Excellent interpersonal and communication skills.
- Experience in good documentation practice.
- Experience in reading/verifying P&IDs.
Please note, we do not require agency assistance with this role.