Senior Validation

5 days ago

Dublin, Ireland CREGG Full time

About the role

Our Sligo based Pharma client is hiring for a Senior Validation Engineer or CQV Engineer to join their team. This is an excellent opportunity to work with a thriving Biologics/Pharmaceutical company offering great career progression opportunities. The CQV Engineer will be responsible for planning, generation, execution and reporting of Commissioning, Qualification and Validation (CQV) of facility, utilities and process equipment with a focus on continuous improvement of pharmaceutical facilities, utilities and equipment.

Contact Gary Keane for a confidential discussion:

Gary Keane

086-1030418 / 091-700814

Responsibilities

- Prepare, execute and report on CQV activities for assigned systems to include C&Q Planning, URS generation, DQ facilitation, TM/RTM, FAT, SAT, IQ, OQ and where applicable PQ activities.
- Prepare, review and approve project documentation, ensuring technical accuracy and adherence to cGMP.
- Support design reviews and system risk assessments with multiple stakeholders.
- Confirm all vendor documentation executions are compliant with GxP practices and the executed documentation is acceptable to support CQV.
- Complete field verifications during static and dynamic (functional) tests.
- Participate in startup activities of energized equipment when necessary.
- Interaction with vendors for project planning.
- Perform system P&ID walkdown with construction prior to handover. Categorization of punch list items & tracking to completion.
- Confirm the site installation is as per approved design specification and meets IQ requirements.
- Participation in and execute design reviews (DQ) when required.
- Where necessary attendance at FATs at Vendor Sites anticipated to be in mainland Europe.
- Provide frequent updates on project status and risk to stakeholders.
- Support the handover of contractor and vendor systems to the user.
- Facilitate/expedite Mechanical Completion in conjunction with the Construction team. Liaise with construction contractors towards successful completion of Construction Turn Over Documentation.
- Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.

Requirements

- At least 4 years’ experience in the biotechnology and/or pharmaceutical industry, in a CQV or similar role.
- Proven experience in authoring, review and execution of CQV activities on a variety of Facility, Utility and Process Equipment is essential.
- Experience with clean utilities and aseptic processing facilities would be an advantage.
- Experience in Computer Systems Validation (CSV) is desirable.
- Experience in temperature mapping of temperature control devices and sterilization cycles is desirable.
- Experience of Commissioning Qualification in a project environment.
- Experience in regulatory and industry standards for GMP and GDP.
- Excellent technical writing skills including deviation reports and validation reports.
- Self-starter with time management and multi-tasking skills.
- Demonstrate ability to drive the completion of tasks, troubleshooting skills and excellent attention to detail.

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