Mantell Associates is partnered with a leading CDMO in their search for a C&Q Manager, responsible for coordinating level 2-4 schedule C&Q activities. You will manage document preparation and coordinate execution for you engineering package. Furthermore, you will have oversight of FAT/SAT and take the C&Q process to close out.

​

C&Q Manager - Responsibilities:

• Develop Level 2 and 3 C&Q (Commissioning & Qualification) Schedule

• Execution Readiness

• Document Preparation management and coordination

• C&Q execution management and coordination

• Resource management including C&Q Doc Prep and C&Q Exec

• Oversight of FATs (Factory Acceptance Tests) and SATs (Site Acceptance Tests)

• Execution of onsite C&Q test cases

• Maintain C&Q input to level 4 schedule and cost report

• Coordinate with Ops regarding PQ (Performance Qualification) and engineering runs

• Adherence to safety, compliance and quality procedures

• Progress tracking and monthly report

• System CFR (Commissioning Final Report) / QFR (Qualification Final Report)

• Complete System Handover

• Technical support for Clean Utilities PQ 1 and EM (Environmental Monitoring) PQ 1

• C&Q Close Out (QFR)

• Participation as SME during Authority Inspection and audits

• Control Training status of C&Q team

​

C&Q Manager - Requirements:

• Minimum 10 years of experience in C&Q Management

• Similar previous positions in a growth project environment (>50mCHF) is mandatory

• Proficiency in Small Molecules is mandatory

• English is Mandatory

• Presence on site mandatory (at least 4 days/week during the design phase, full time on site during the execution phase)

​

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.