CQV Lead
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| Job Type | Contractor |
| Area | Tipperary, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +3539833013 |
| Job Ref | #1002214 |
| Job Views | 247 |
- Description
- CQV Lead – Team Horizon
Team Horizon currently has an exciting opening for a CQV Lead manage a team of C&Q Engineers on high profile client site throughout the project lifecycle.
What you will be doing:
As the Lead CQV Engineer you will report to the department manager / site commissioning manager and you will be responsible for coordinating CQV resources, deliverables and activities from the validation approach definition, design review, turn-over systems definition and C&Q activities at site.
Experience in the Validation Master Plan, Commissioning Master Plan, project procedures and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ) will be very beneficial for this role.
You will be responsible for the Design Review (DR) process and GMP Risk Assessment (FMEA).
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 Jacobs 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 Jacobs 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
Mentor for junior staff members.