Senior Production Engineer, Fractionation

Century Center

Bachelor's degree in engineering
5+ years pharmaceutical manufacturing experience
Aseptic and fractionation processing expertise
The Senior Production Engineer provides strategic engineering support to ensure optimal asset performance and compliance throughout the pharmaceutical asset lifecycle

Job Summary

  • The Senior Production Engineer provides strategic engineering support to ensure optimal asset performance and compliance throughout the pharmaceutical asset lifecycle.
  • This role drives risk-based asset management strategies aligned with ISO 55000 principles and GMP requirements while leading complex troubleshooting and failure investigations.
  • Candidates will mentor junior staff, lead continuous improvement initiatives, and act as a subject matter expert during regulatory audits and inspections.

Matching Summary

The Senior Production Engineer provides strategic engineering support to ensure optimal asset performance and compliance throughout the pharmaceutical asset lifecycle.

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering
  • 5+ years pharmaceutical manufacturing experience
  • Aseptic and fractionation processing expertise
  • Root cause analysis and CAPA implementation
  • GMP compliance and contamination control
  • SAP CMMS data analysis
  • ISO 55000 asset management principles

Nice-to-have

  • Six Sigma or Lean principles knowledge
  • Mentoring junior engineers and technicians
  • Experience with capital project execution
  • Strong stakeholder engagement skills

Key Requirements

  • Bachelor's degree in Mechanical, Chemical, or Biomedical Engineering
  • Master's degree preferred
  • 5+ years of engineering experience in pharma
  • Proven experience supporting cGMP environments
  • Knowledge of sterile filling operations

Work Rights

Not specified

Tailored Resume

Cover Letter