CQV Engineer

Cpl in partnership with Pfizer Grange Castle are looking to hire DS2 CQV Engineer on an 9-month contingent contract.

Introduction:

The DS2 Project is Design, Construction and fit-out of a multiproduct large-scale Cell Culture facility, including 6x bioreactors (13,200L), associated scale-up trains, support equipment, and a single purification suite to double existing site capacity. Forecasted demand of licensed and pipeline products exceeds the available capacity within the Pfizer Global Supply (PGS) network, hence the requirement for this project.

Location: Grange Castle/A&E Firm (Jacobs, Dublin Office)

Project Background:

Construction on site is significantly advanced (PM Group as Construction Managers), with many systems now mechanically complete. Utilities and process equipment commissioning and qualification is underway.

Purpose of the Role:

Your role will primarily be execution of commissioning and qualification of process equipment and utilities that are within the DS2 project scope. There will be some development of the C&Q package of documentation. The job holder will provide technical expertise to ensure that systems, equipment, and processes are designed, installed, commissioned, and qualified to the agreed specifications.

Reporting to the CQV Lead role is responsible to:

• Perform shakedown and commissioning and qualification of systems.
• Participate in construction system completion walkdowns.
• Generate CQV documents at project level and for specific equipment/systems. Liaising with Quality, Engineering and CQV to align on Critical parameters and document content.
• Track and confirm closure of actions items identified from walkdowns, FAT, HAZOP, Design Qualification and other reviews.
• Maintain a strong interface with the Automation and Engineering teams to ensure that the information flow meets the needs of the Automation and Engineering teams, resolving issues as they arise.

Education/Experience:

• B.Sc. /B.Eng. degree in engineering discipline, with particular emphasis mechanical or process engineering.
• Minimum of 4 years’ experience from biotechnology or pharmaceutical GMP manufacturing/CQV environment.
• Demonstrated ability to work on own initiative and proactively respond to business needs.
• Excellent interpersonal and communication skills.
• Familiar with Delta-V & Navisworks an advantage.