Job Ref: 3595Recruiter: Tom Doyle
Country: IrelandLocation: Tullamore Co.Offaly
Job Category: Construction, Process, Pharma Life Science,Salary Range: €Up to €90 per hour for the right candidate

Job Description

CQV Area Lead

Location: Tullamore Co.Offaly

Rate: Up to €90 euro per hour for the right candidate.

Project: Biopharma Plant

Long term contract:  To end of December 2023.

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 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 Company and Clients PM.
  • Contractors and Vendors management and coordination.
  • Final Handover reports to the Client users.

The Area 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 required for the role include:

  • 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.

Contact Tom Doyle at kppm:  P: 086 8205038 | E: tom@kppm.ie

 

 

or email tom@kppm.ie

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