Utilities CQV Engineer

Utilities CQV Engineer

PROCHEM Engineering

Dublin, Ireland

Role Summary:

• 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.

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