Engineering Utilities CQV Specialist
CK Group is recruiting for an Engineering Utilities CQV Specialist to join a company in the Pharmaceutical industry at their site based in Swords, Dublin on a contract basis for 12 months and has an hourly rate of up to €40.
The Company: Our client has a long history of pushing the boundaries of science in order to help fight some the worlds most urgent global health challenges. This role is based at a state of the art biologics operation where they formulate and fill vaccines and biologic products.
The Location: This role is located in Swords, an historic satellite town of Dublin. Swords is located very close to Dublin airport and has excellent road and public transport links to Dublin City and surrounding areas.
The Role: This role 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 on site.
- Generation of qualification risk assessment/testing matrix for qualification protocols and supporting documents in line with User Requirements/Equipment Specifications/and cGMP compliance standards.
- Preparation and approval of Utilities Validation SOPs.
- Preparation and approval of Validation test equipment SOP's.
- Management of Validation Test equipment with support from site maintenance management team. (Calibration/System Maintenance and Calibration Event Handling).
- Qualification of Validation test equipment.
- 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.
- 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.
Your Background: To succeed in this role you will have the following skills and experience:
- Minimum qualification BSc or MSc/M.Eng Degree in Engineering or similar or have equivalent working experience.
- Must have excellent verbal and written communication skills.
- Extensive in an Engineering CQV role with extensive cGMP experience in Commissioning Qualification & Validation, ideally covering GMP Critical Utilities Equipment Engineering.
- Have good understanding of Instrumentation/Calibration, Utilities Equipment incl. HVAC, WFI/RO/PW, Clean Steam Gases, Refrigeration Systems.
- In depth knowledge and experience with validation test equipment/systems. A good understanding of associated Maintenance/Calibration requirements of such systems is also a requirement.
- Have the capability and experience to manage Vendors and Contractors supporting PQ activities.
- Ability to work independently and as part of a team in a cross functional collaborative environment.
For more information or to apply for this position, please contact Natasha on 01246 457739 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47107 in all correspondence.