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Job Description
Seeking Utilities CQV Engineer for 11-month fixed term contract in Dublin, to implement commissioning and qualification of clean utilities and controlled environmental devices.
**Job Description:**
- Implement commissioning and qualification of new/modified clean utilities and non-GMP utilities and controlled environmental devices sitewide.
- Provide technical expertise to ensure systems and equipment are installed, commissioned and qualified to Pfizer and regulatory specifications.
**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 ECMs.
- Participate in design review for new/modified utility systems.
- Participate in construction system mechanical completion walkdowns.
- 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.
**Requirements:**
- BSc/BEng 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 or HVAC is an advantage.
- 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.