CQV Area Lead

2022-05-19 17:29:422049-11-18Team Horizon
Job TypeRemoteContractor
Start Date
AdvertiserHilda Lynn
Job Ref#1002489
Job Views210
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
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
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