Job Description
Headcount Solutions are seeking to recruit a CQV Site Engineer for one of our multinational clients site in Co.Tipperary.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) experienceIdentify the appropriate Commissioning and Qualification strategy to apply on specific project and define the list of activities requiredReview and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirementsEnsure site project execution is undertaken in compliance with company guideline, department procedures and safety standardsBe familiar with the Mechanical Completion procedure and Construction scope of work (Walkdown, system acceptance, punch list and follow up)Schedule preparation and progress reviewOrganize and review daily activities of other CQV Engineers assigned to the projectContractors and Vendors management and coordination.QualificationsDegree or equivalent in an engineering related discipline10+ years of experience in commissioning and qualification activities for pharmaceutical facilitiesStrong leadership and team player abilityPrevious experience as manager/leader of C&Q teamStrong knowledge of ISPE and ASTM E2500Proven experience with international pharmaceutical projects.
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