CQV Area Lead
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Job Type | Contractor |
Area | Dublin, Ireland |
Sector | EngineeringQuality |
Start Date | |
Advertiser | David Connolly |
Job Ref | 1002814 |
Job Views | 520 |
- Description
- CQV Area Lead
Team Horizon is seeking a CQV Area Lead for a leading engineering company 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, turn-over systems definition and C&Q activities at site.
Why you should apply:
• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• You enjoy working on exciting projects and want to work with a global manufacturing sites in Dublin.
• Excellent contracting rates.
What you will be doing:
• 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 senior management and Clients PM.
• Contractors and Vendors management and coordination.
• Final Handover reports to the Client users.
What you need to apply:
• 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.
• To be able to mentor for junior staff members.