C&Q Manager - CDMO

Posted 06 June 2024
Salary Negotiable
Job type Contract
Discipline Small Molecule
Contact NameRhys Jones

Job description

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.