The Senior Production Engineer provides technical leadership to ensure optimal asset performance and compliance throughout the pharmaceutical asset lifecycle
Job Summary
The Senior Production Engineer provides technical leadership 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 partnering with cross-functional teams.
The position requires leading complex troubleshooting, failure investigations, and continuous improvement initiatives for separation, extraction, purification, and filling processes.
Matching Summary
The Senior Production Engineer provides technical leadership 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 methodologies
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
Continuous improvement initiative leadership
Key Requirements
Bachelor's degree in Mechanical, Chemical, or Biomedical Engineering
Master's degree preferred
5+ years of engineering experience in pharmaceutical manufacturing
Proven experience supporting cGMP environments
Knowledge of sterile filling operations and aseptic techniques