Instrumentation and Calibration Manager

QCS Staffing Ltd

North Carolina

Sur place

USD 120 000 - 150 000

Plein temps

Il y a 2 jours
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Résumé du poste

QCS Staffing Ltd is seeking an Instrumentation and Calibration Manager to support a major pharma build in North Carolina. This is an initial 12-month contract within a life sciences program.

You will own end-to-end calibration; develop strategy, plan, and schedule; define calibration requirements and acceptance criteria; lead initial calibration execution in line with cGMP to support C&Q readiness.

Qualifications

  • GMP calibration management experience.
  • Strong metrology, traceability and out-of-tolerance knowledge.
  • Experience with capital or greenfield pharma projects through C&Q and commissioning.
  • Demonstrated contractor or multi-disciplinary team leadership.

Responsabilités

  • Own end-to-end calibration program from instrument identification to initial calibration execution and turnover.
  • Develop strategy, execution plan, resource model and schedule aligned with master project milestones.
  • Define calibration requirements, frequencies, tolerances and acceptance criteria for process and utility instruments.
  • Lead initial calibration execution to ensure instruments are calibrated, documented and released to C&Q and cGMP requirements.

Connaissances

GMP calibration management
metrology/traceability/OOT
capital or greenfield project
contractor leadership

Formation

Bachelor’s in Engineering or Instrumentation

Description du poste

Instrumentation and Calibration Manager – US, North Carolina – Initial 12-Month Contract – Life Sciences

Be part of a next-generation pharmaceutical project that’s transforming how medicines are made. We’re supporting a major new-build facility in North Carolina, a multi-billion-dollar investment designed to push the boundaries of science and engineering. We’re looking for an Instrumentation and Calibration Manager to support this project and help deliver this world-class program.

What you’ll deliver:
  • Own the end-to-end calibration program, from instrument identification and planning during design through initial calibration execution and TCCC.
  • Develop the strategy, execution plan, resource model and resource-loaded schedule, integrated with the master project schedule, system turnover, C&Q and TCCC milestones.
  • Support definition of calibration requirements, frequencies, tolerances and acceptance criteria for process, clean utility, HVAC, facility and automation instruments, based on criticality and intended use.
  • Lead initial calibration execution so instruments are calibrated, documented and released against approved specifications and cGMP requirements in time to support C&Q.
What you’ll need:
  • Bachelor’s in Engineering, Instrumentation or a related technical discipline with strong, relevant experience, or an equivalent combination of education and experience.
  • Proven GMP calibration management and strong metrology/traceability/OOT knowledge.
  • Capital or greenfield project experience through C&Q and operational readiness.
  • Contractor or multidisciplinary team leadership.
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