Chief Reliability Officer

6 days ago


Noblesville, United States Entegee Full time

Job Title: Chief Reliability Officer - Engineering and Facilities

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About Us: Entegee is a leading provider of custom automation projects, specializing in controls and robotic solutions worldwide.

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Estimated Salary Range: $150,000.00 to $160,000.00 per year

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Job Description:

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  • We are seeking an experienced Director of Engineering Facilities and Reliability to lead our engineering team in designing 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:

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  • 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.

Requirements:

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  • 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:

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  • Knowledge of US and international Process Validation regulations.
  • Familiarity with Programmable Logic Controllers (PLCs) and Human-Machine Interfaces (HMIs).

About the Role:

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This is a unique opportunity to join a dynamic team and contribute to the success of our organization.

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We are committed to equal opportunities and welcome applications from diverse candidates.

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To learn more about our company culture and values, please visit our website at https://www.entegee.com/candidate-privacy-information-statement/

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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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EOE/Veterans/Disabled


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