CQV Site Engineer

2 weeks ago

Dublin, Dublin City, Ireland Headcount Solutions Full time

Headcount Solutions are seeking to recruit a CQV Site Engineer for one of our multinational clients site in Dublin. The Lead CQV Engineer reports to the department manager / site commissioning manager and is accountable to coordinate CQV resources, deliverables and activities from the validation approach definition, design review, turn-over systems definition and C&Q activities at site. Responsibilities: Manage team of C&Q Engineers on high profile client site throughout the project lifecycle. Strong experience with 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) experience Identify the appropriate Commissioning and Qualification strategy to apply on specific project and define the list of activities required Review and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements Ensure site project execution is undertaken in compliance with company guideline, department procedures and safety standards Be familiar with the Mechanical Completion procedure and Construction scope of work (Walkdown, system acceptance, punch list and follow up) Schedule preparation and progress review Organize and review daily activities of other CQV Engineers assigned to the project Contractors and Vendors management and coordination. Qualifications Degree or equivalent in an engineering related discipline 10+ years of experience in commissioning and qualification activities for pharmaceutical facilities Strong leadership and team player ability Previous experience as manager/leader of C&Q team Strong knowledge of ISPE and ASTM E2500 Proven experience with international pharmaceutical projects.

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    2 weeks ago

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