Director of Engineering Facilities and Reliability

2 weeks ago


Noblesville, United States Entegee Full time
Job SummaryEntegee is seeking a seasoned Director of Engineering Facilities and Reliability to lead their engineering team in designing and implementing control systems compliant with Process Validation regulations. The ideal candidate will have expertise in cGMP manufacturing, equipment maintenance, and capital project management within the biotechnology or pharmaceutical industry.Key Responsibilities
  • Develop and implement a risk-based approach to maintenance with regular risk assessments.
  • Establish a reliability program to maximize equipment uptime and ensure all equipment, facilities, and automation systems meet cGMP requirements.
  • 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.
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).
Compensation

$150,000.00 to $160,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, 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.



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