CQV Area Lead
| Job Type | RemoteContractor |
| Area | Offaly |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +3539833013 |
| Job Ref | #1002489 |
| Job Views | 210 |
- Description
- 2489 - CQV Area Lead
Team Horizon is seeking a CQV Area Lead who 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.
This role will work hybrid for the rest of the calender year and then will move to site for 2023.
Why you should apply:- You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success.
- They put their people first and live their diversity and inclusion values embracing all perspectives.
- You enjoy working in a culture of learning and collaboration and making a positive impact.
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 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
- 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
