Lead Automation Strategist for cGMP Manufacturing

5 days ago


Noblesville, United States Entegee Full time

Join a leading automation solutions provider, Entegee, as they seek an experienced Director of Engineering Facilities and Reliability to spearhead their cGMP manufacturing initiatives.

About the Role

This key position will be responsible for ensuring all equipment, facilities, and automation systems meet stringent cGMP requirements. You will implement a risk-based approach to maintenance, establishing a reliability program to maximize equipment uptime and monitor environmental conditions for aseptic manufacturing requirements.

The successful candidate will lead the Engineering team in designing control systems compliant with Process Validation regulations, develop a Change Control system for managing changes to control systems, and collaborate with Validation and Quality Assurance teams for qualification/validation activities.

Awarded an estimated salary range of $150,000 to $160,000 per year, this is an exceptional opportunity to leverage your expertise in capital project management, Total Productive Maintenance, condition monitoring, and predictive maintenance.

Responsibilities
  • Ensure compliance with cGMP requirements for equipment, facilities, and automation systems.
  • Implement a risk-based approach to maintenance, including regular risk assessments.
  • Develop and lead a reliability program to maximize equipment uptime.
  • Monitor environmental conditions for aseptic manufacturing requirements.
  • Collaborate with Validation and Quality Assurance teams for qualification/validation activities.
  • Design control systems compliant with Process Validation regulations.
  • Develop a Change Control system for managing changes to control systems.

As a seasoned professional in the biotechnology or pharmaceutical industry, you will bring expertise in automation controls, alert, and data collection/retention systems, as well as experience with CMMS software.



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