Director Engineering Facilities and Reliability

3 months ago


Noblesville, United States Entegee Full time
Job DescriptionJob Description

Summary: Seeking a Director of Engineering Facilities and Reliability with expertise in cGMP manufacturing, equipment maintenance, and capital project management within the biotechnology or pharmaceutical industry.

Job Requirements:

  • Bachelor's degree in engineering.

  • 15+ years of relevant experience in cGMP manufacturing and facility maintenance.

  • 5+ years in a leadership role.

  • Experience with automation controls, alert, and data collection/retention systems.

  • Working knowledge of HVAC and clean utility systems.

  • Experience managing capital projects.

  • Experience in Total Productive Maintenance, condition monitoring, and predictive maintenance.

  • Direct experience in equipment qualification and process validation.

  • CMMS software experience.

Preferred Skills:

  • Knowledge of US and international Process Validation regulations.

  • Familiarity with Programmable Logic Controllers (PLCs) and Human-Machine Interfaces (HMIs).

Job Responsibilities:

  • Ensure all equipment, facilities, and automation systems meet cGMP requirements.

  • Implement a risk-based approach to maintenance with regular risk assessments.

  • Establish a reliability program to maximize equipment uptime.

  • Monitor environmental conditions for aseptic manufacturing requirements.

  • Lead the Engineering team in designing control systems compliant with Process Validation regulations.

  • Develop a Change Control system for managing changes to control systems.

  • Collaborate with Validation and Quality Assurance teams for qualification/validation activities.

  • Implement advanced process control strategies to optimize production processes.

  • Develop the Site's capital plan aligned with strategic objectives and regulatory requirements for equipment qualification.

  • Prepare project proposals considering cost-benefit analyses ensuring regulatory compliance.



Pay Details: $150,000.00 to $160,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.

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