Job Title: Utilities CQV Engineer
We are seeking a skilled professional to join our organization in an 11-month contract capacity at Pfizer's Grange Castle site. The successful candidate will be responsible for generating documentation for cGMP commissioning/qualification of systems and equipment, including CTP/IQ/OQ/PQ protocols and reports.
Key Responsibilities:
* Develop and implement CTPs, IQ, OQ, PQ Protocols in the field.
* Manage system change controls and ECMs.
* Participate in design review for new/modified utility systems.
* Perform temperature mapping of equipment.
* Verify pre and post study calibration settings.
* Operate according to SOPs developed for validation, manufacturing operations, and cGMP compliance.
* Implement changes required to resolve deviations/events effectively.
Requirements:
* Bachelor's degree in engineering with 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.
* Qualification of clean utilities or HVAC experience is an advantage.
* Ability to work independently and respond to business needs proactively.
* Excellent interpersonal and communication skills.
* Good documentation practices.
* Reading/verifying P&IDs experience.