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The Lead CQV Engineer reports to the department manager and is accountable to coordinate CQV resources, deliverables and activities from the validation approach definition, design review, turn-over systems definition till C&Q activities at site.
Responsible for leading a small team of C&Q Engineers as part of an integrated small projects group of managed services on site.
• Manage team of C&Q Engineers on high profile client site throughout the project life cycle.
• 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 Company 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 (Walk down, system acceptance, punch list and follow up)
• Schedule preparation and progress review
• Organise 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
• Contractor and Vendor management and coordination
• Final Handover reports to the Client users
• 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