Overview
Ref. *****
Senior CQV Engineer – Clean Utilities
Asset Recruitment is currently seeking a Senior Engineer – Clean Utilities on behalf of our client, a world-class EPCM company, to join their team on a Pharmaceutical project.
Reporting to the department manager / site commissioning manager, the Senior CQV Engineer is accountable to coordinate CQV resources, deliverables and activities from the validation approach definition, design review, turnover systems definition and C&Q activities at site.
This is an initial 14-month contract position, full-time onsite based in in Co.
Tipperary.
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 E****.
Experience with international pharmaceutical projects.
Experience in mentoring junior staff members.
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