CQV Site Engineer

4 weeks ago

Dublin, Dublin City, Ireland Headcount Solutions Full time
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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