Overview
Headcount Solutions are seeking to recruit a CQV Site Engineer for the client 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, turnover systems definition and CQV activities at site.
Responsibilities
* Manage team of CQV Engineers on a 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 guidelines, 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 CQV team.
* Strong knowledge of ISPE and ASTM E2500.
* Proven experience with international pharmaceutical projects.
Senior / Employment details
* Seniority level: Mid-Senior level
* Employment type: Contract
* Industry: Pharmaceutical Manufacturing
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