C&Q Manager - CDMO

Posted 08 July 2024
Salary Negotiable
Job type Contract
Discipline Small Molecule
Contact NameSiobhan Mcloughlin

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.