CQV Lead
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Job Type | Contractor |
Area | Offaly |
Sector | Engineering |
Start Date | |
Advertiser | Hilda Lynn |
Telephone | +353 98 33013 |
Job Ref | #1002623 |
Job Views | 196 |
- Description
- 2623 - CQV Lead
Team Horizon is seeking a CQV Lead to manage a team of C&Q Engineers throughout the project lifecycle on our client pharmaceutical site in Tullamore.
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 Clients PM
Contractors and Vendors management and coordination
Final Handover reports to the Client users
As the Lead CQV Engineer you will report 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.
What you need to apply:
Degree or equivalent in an engineering related discipline
5 - 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