CQV Site Engineer

Asset Recruitment; Munster; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

A leading recruitment agency is seeking a CQV Site Engineer to oversee a team on a pharmaceutical project in Co. Tipperary. The position offers a hybrid work arrangement and requires over 10 years of relevant experience. Candidates should have a degree in engineering and proven leadership skills in commissioning and qualification activities. This initial 14-month contract is a great opportunity to contribute to high-profile projects.

Qualifications

• 10+ years of experience in commissioning and qualification activities for pharmaceutical facilities.
• Proven experience as manager/leader of C&Q team.
• Strong knowledge of ISPE and ASTM E2500.

Responsibilities

• Manage team of C&Q Engineers on high profile client site throughout the project lifecycle.
• Develop Validation Master Plan, project procedures, and qualification protocols.
• Coordinate CQV activities and report to company and Client's PM.

Skills

Team Leadership

Project Management

GMP Knowledge

Validation Protocols

Education

Degree in Engineering or equivalent

Job description

Overview

Ref. 01315

CQV Site Engineer

Asset Recruitment is currently seeking a CQV Site Engineer on behalf of our client, a world-class EPCM company, to join their team on a Pharmaceutical project.

This is an initial 14-month contract position based in in Co. Tipperary, offering a hybrid work arrangement.

Responsibilities

• Manage team of C&Q Engineers on high profile client site throughout the project lifecycle.
• Develop Validation Master Plan, Commissioning Master Plan, project procedures and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ).
• Design Review (DR) process and GMP Risk Assessment (FMEA).
• Identify the appropriate Commissioning and Qualification strategy to apply on specific project and define the list of activities required.
• Be familiar with the Mechanical Completion procedure and Construction scope of work (Walkdown, system acceptance, punch list and follow up).
• Audit and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements.
• Project management principles to coordinate CQV activities and reporting to the company and Client’s PM.
• Contractors and Vendors management and coordination.
• Final Handover reports to the Client users.

Requirements

• 10+ years of experience in commissioning and qualification activities for pharmaceutical facilities
• A Degree or equivalent in an engineering related discipline
• Proven experience as manager/leader of C&Q team
• Excellent leadership and team player skills, liaising directly with client and other project key functions
• Strong knowledge of ISPE and ASTM E2500
• Experience with international pharmaceutical projects
• Experience in mentoring junior staff members