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Role 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 our Client’s 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
- Organise and review daily activities of other CQV Engineers assigned to the project
- Project management principles to coordinate CQV activities and reporting to our Client’s and PMs
- 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.
Role Requirements:
- Degree or equivalent in an engineering related discipline
- 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
What’s in it for you:
- Competitive hourly rate
- Stable contract duration
- Opportunity to work with an exciting and expanding engineering consultancy