Direct message the job poster from Prochem Engineering
Recruitment Manager at Prochem Engineering
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 site-wide.
* 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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Pharmaceutical Manufacturing and Engineering Services
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