Clean Utilities CQV Engineer - Ballydine, Tipperary
Work Location: Office Based / Hybrid
Job Summary: We are seeking a Clean Utilities CQV Engineer to manage team of C&Q Engineers on high profile client site throughout the project lifecycle.
Key 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.
* Investigate and resolve technical issues with assistance from engineers and/or suppliers.
* 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.
* Project management principles to coordinate CQV activities and reporting to Clients PM.
* Contractors and Vendors management and coordination.
* Final Handover reports to the Client users.
Requirements:
* 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, liaising directly with client and other project key functions.
* Previous experience as manager/leader of C&Q team.
* Strong knowledge of ISPE and ASTM E2500.
* Proven experience with international pharmaceutical projects.
* Mentor for junior staff members.
Benefits:
* Long term contract roles min 12 months.
* Hybrid.
* Contract rates of €70 - €80 per hour.