Job Description

CQV Lead Engineer  We are looking for a CQV Engineer for this management role at lead level based at our client’s pharmaceutical project site in Ballydine in Co Tipperary

Suitable candidates will have:

An Engineering or Science Degree + 10 years experience working in Commissioning and Qualification on large scale pharmaceutical projects.

Strong Leadership and management experience of Commissioning and Qualification Teams on large scale Pharmaceutical Projects.

Strong knowledge of ISPE and ASTM E2500

Proven experience with international pharmaceutical projects

Proven experience of mentoring CQV staff members.

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 the company’s engineers and/or suppliers.
• Ensure site project execution is undertaken in compliance with company guidelines, 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 the company and Clients PM.
• Contractors and Vendors management and coordination.
• Final Handover reports to the Client users.
• In the role of Lead CQV Engineer you will report to the department manager / site commissioning manager, and you will be 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 is a long term contract role 2 years + and can be offered on a Ltd Co. Hourly rate or Salary (fixed term contract) / € negotiable

For further information or to apply please contact:   Tom Doyle at kppm, P: 086 8205038.  E: tom@kppm.ie

or email tom@kppm.ie

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