CQV Project Manager

  • Job Reference: 470215025-2
  • Date Posted: 11 January 2022
  • Recruiter: Confidential
  • Location: Ireland
  • Salary: On Application
  • Sector: Engineering
  • Job Type: Contract

Job Description


* CQV Subject Matter Expert, , preferably with experience of FDA and EMA requirements

* Directs all CQV Activities on Site

* In consultation with key stakeholders develop CQV Strategy for the project.

* The CQV Project Manager reports to the Project Director and is accountable to coordinate CQV resources, deliverables and activities including validation approach definition, design reviews, turn-over systems definition.

* 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 vendors.

* 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

* Project management principles to coordinate CQV activities and reporting to Main Client Representatives and Project Director

* Contractors and Vendors management and coordination

* Final Handover reports to the Client users


* 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

* Knowledge of FDA and EMA requirements for CQV


* 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