Website Asset Recruitment

Asset Recruitment

Ref. 01315

Senior CQV Engineer – Clean Utilities

Asset Recruitment is currently seeking a Senior Engineer – Clean Utilities on behalf of our client, a world-class EPCM company, to join their team on a Pharmaceutical project.

Reporting to the department manager / site commissioning manager, the Senior CQV Engineer is accountable to coordinate CQV resources, deliverables and activities from the validation approach definition, design review, turnover systems definition and C&Q activities at site.

This is an initial 14-month contract position, full-time onsite based in in Co. Tipperary.

Responsibilities include:

• Manage team of C&Q Engineers on high profile client site throughout the project lifecycle.
• Develop 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)
• Identify the appropriate Commissioning and Qualification strategy to apply on specific project and define the list of activities required
• Be familiar with the Mechanical Completion procedure and Construction scope of work (Walkdown, system acceptance, punch list and follow up)
• Audit and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements
• Project management principles to coordinate CQV activities and reporting to the company and Client’s PM
• Contractors and Vendors management and coordination
• Final Handover reports to the Client users.

Requirements:

• 10+ years of experience in commissioning and qualification activities for pharmaceutical facilities
• A Degree or equivalent in an engineering related discipline
• Proven experience as manager/leader of C&Q team
• Excellent leadership and team player skills, liaising directly with client and other project key functions
• Strong knowledge of ISPE and ASTM E2500
• Experience with international pharmaceutical projects
• Experience in mentoring junior staff members

 

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