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) 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.