Overview
Ref. 01315
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 E2500.
* Experience with international pharmaceutical projects.
* Experience in mentoring junior staff members.
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