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CQV area Lead - Tullamore

  • Location: Tullamore
  • Salary: €80 - €90 per hour
  • Job Type:Permanent

Posted 4 months ago

  • Sector: Advanced Facilities
  • Contact: Steven Garland
  • Contact Email: Steven.Garland@nrl.ie
  • Contact Phone: +353 (87) 662 4838
  • Start Date: 2022-05-18
  • Expiry Date: 17 June 2022
  • Job Ref: SG1178
Area Lead for Solution Preparation (Media & Buffer) & Cleaning (CIP skids, Autoclave & Washers)

Responsibilities:

•             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

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.

 

Qualifications Key Competencies:

•             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