Headcount Solutions Ltd

<< Back

Utilities Specialist

Reference ID : 01922MQ
Category :
  • Pharma / Biotech
Date Posted : Jun 19, 2020
Job Location
  • Dublin
Experience : Minimum 5 years
Salary : Negotiable - DOE
Employment Type
Michael McQuade
Contact Number : 086-0435195
Headcount Solutions is recruiting a Utilities Specialist to join team at our clients biotech facility in Dublin.

Principal Responsibilities

The job-holder will work as part of a multi-functional utilities team and will be responsible for the qualification, validation maintenance, revalidation and periodic review activities associated with GMP Critical Utility equipment and systems

  • Generation of qualification risk assessment/testing matrix for qualification protocols and supporting documents in line with User Requirements/Equipment Specifications/ MSD and cGMP compliance standards.
  • Preparation and approval of Utilities Validation and Validation test equipment SOPs
  • Management of Validation Test equipment with support from site maintenance management team. (Calibration/System Maintenance and Calibration Event handling)
  • Develop, review and execute GMP critical utility Performance Qualification (PQ) protocols and PQ reports for GMP Critical systems e.g. HVAC, RO/PW/WFI, Clean Steam, Clean Compressed Gasses, walk in cold storage.
  • Equipment/System assessments for ‘Computer System Qualification’ requirements and ‘Execution of Electronic Records and Electronic Signatures’ requirements.
  • Identify, document and track validation events
  • Full oversight of all personnel and contractors participating or executing PQ activities
  • Responsible for ensuring documentation being leveraged for PQ testing from project commissioning phase/IQ/OQ are referenced as per associated qualification, referencing procedures.
  • Responsible for validation tasks/actions associated with quality system change controls and investigations where required.
  • Development/Generation of Utilities Validation Master Plan.
  • Periodic review and revalidation assessment.

Qualifications & Requirements

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

Apply Online

To apply for this opportunity, simply add your details to the form below and upload your CV (in word document format). One of our specialist consultants will contact you to acknowledge your application to discuss the opportunity further.
Your Name *  
Contact Number *  
Email Address *   
Upload CV
Additional Notes