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 E****
Proven experience with international pharmaceutical projects.