Sr. Manager, Engineering

PCI Pharma Services

Madison, WI, US
Cgmp adherence and compliance
Process engineering and calibration
Site capex project management
The Senior Manager leads all Engineering, Instrumentation & Controls, and Metrology functions to ensure the highest level of quality and cGMP adherence at the Madison site

Job Summary

  • The Senior Manager leads all Engineering, Instrumentation & Controls, and Metrology functions to ensure the highest level of quality and cGMP adherence at the Madison site.
  • This role is responsible for managing site CAPEX projects, overseeing departmental budgets, and driving a culture of Lean and Continuous Improvement.
  • The position requires advanced knowledge of PLC programming for GMP automated systems and active participation in regulatory and client audits.

Matching Summary

The Senior Manager leads all Engineering, Instrumentation & Controls, and Metrology functions to ensure the highest level of quality and cGMP adherence at the Madison site.

Skills & Requirements

Must-have

  • cGMP adherence and compliance
  • process engineering and calibration
  • site CAPEX project management
  • Lean and Continuous Improvement
  • PLC programming and integration
  • team leadership and development
  • regulatory audit support

Nice-to-have

  • CDMO customer exposure experience
  • financial systems and accounting knowledge
  • ESG program leadership
  • aseptic manufacturing background
  • global team collaboration skills

Key Requirements

  • Bachelor's degree in engineering preferred
  • 8+ years technical engineering support in biopharma
  • 5-10 years management experience with professional staff
  • Operational background in cGMP aseptic manufacturing
  • Experience working with regulators during inspections

Work Rights

Not specified

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