Clean Utility Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeUtilities Full time €60,000 - €80,000

We are seeking a highly skilled Utilities Engineer to join our team. This role will involve the commissioning and qualification of new/modified clean utilities and non GMP utilities, as well as controlled environmental devices sitewide.

Job Overview:

This is an exciting opportunity for a professional with experience in temperature mapping, clean utility qualification, and HVAC systems. The ideal candidate will have a strong understanding of regulatory specifications and be able to provide technical expertise to ensure that systems and equipment meet Pfizer's standards.

Responsibilities:
  • Documentation Generation: Develop documentation for cGMP commissioning/qualification of systems and equipment, including CTP/IQ/OQ/PQ protocols and reports.
  • System Change Control: Raise and implement system change controls and ECMs.
  • Design Review Participation: Participate in design review for new/modified utility systems.
  • Construction Walkdowns: Participate in construction system mechanical completion walkdowns.
  • Clinical Trials Protocols: Perform execution of CTPs, IQ, OQ, PQ Protocols in field.
  • Temperature Mapping: Perform execution of temperature mapping of equipment.
  • Calibration Verifications: Perform pre and post study calibration verifications.
  • Validation and Compliance: Operate according to SOPs developed for validation, validated manufacturing operations and cGMP compliance.
  • Deviation Resolution: Develop and implement changes required to resolve deviations/events effectively.
Requirements:
  • Bachelor's 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 live expertval 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

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