DS2 CQV Engineer

Commission for Railway Regulation; Dublin; On-site; EUR 45,000 - 70,000; Full time

Job summary

A leading engineering consultancy is looking for a DS2 CQV Engineer in Dublin. The role involves executing commissioning and qualification of process equipment in a large-scale cell culture facility. Candidates should have a B.Sc. in engineering, a minimum of 4 years in a GMP environment, and excellent communication skills. The position offers a great opportunity to work on advanced biotechnology projects and contribute to increasing production capacity.

Qualifications

• 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.

Responsibilities

• 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.
• Track and confirm closure of action items identified from various reviews.
• Maintain a strong interface with the Automation and Engineering teams.

Skills

Interpersonal skills

Communication skills

Initiative

Familiarity with Delta-V

Familiarity with Navisworks

Education

B.Sc./B.Eng degree in engineering

Job description

Cpl in partnership with Pfizer Grange Castle are looking to hire DS2 CQV Engineer on an 11-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.

Responsibilities

• 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 action 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.

General Information

Job Title: DS2 CQV Engineer

Department: DS2 Project Team

Position Reports to: DS2 CQV Lead

Education / Experience

• B.Sc./B.Eng degree in an 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.