Chief Reliability Officer

4 weeks ago

Noblesville, United States Entegee Full time

Job Summary:

Entegee seeks a highly skilled Chief Reliability Officer - Engineering and Facilities to oversee the design, implementation, and maintenance of its engineering and facilities operations. The ideal candidate will have a strong background in cGMP manufacturing, equipment maintenance, and capital project management, with a proven track record of ensuring compliance with industry regulations.

About Entegee:

Entegee specializes in custom automation projects and is a major player in the world of controls and robotic solutions globally. We are committed to helping our employees grow and develop their careers, with a focus on providing opportunities for professional advancement.

Job Responsibilities:

  • Ensure Compliance: Ensure all equipment, facilities, and automation systems meet cGMP requirements, implementing a risk-based approach to maintenance with regular risk assessments.
  • Reliability Program: Establish a reliability program to maximize equipment uptime, monitor environmental conditions for aseptic manufacturing requirements, and lead the Engineering team in designing control systems compliant with Process Validation regulations.
  • Change Control: Develop a Change Control system for managing changes to control systems, collaborating with Validation and Quality Assurance teams for qualification/validation activities.
  • Capital Projects: Develop the Site's capital plan aligned with strategic objectives and regulatory requirements for equipment qualification, preparing project proposals considering cost-benefit analyses ensuring regulatory compliance.
  • Team Leadership: Lead the Engineering team in designing and implementing control systems, advanced process control strategies, and automation solutions to optimize production processes.

Requirements:

  • Education: Bachelor's degree in engineering.
  • Experience: 15+ years of relevant experience in cGMP manufacturing and facility maintenance, with 5+ years in a leadership role.
  • Skills: Experience with automation controls, alert, and data collection/retention systems, working knowledge of HVAC and clean utility systems, and CMMS software experience.
  • Regulatory Knowledge: Knowledge of US and international Process Validation regulations, familiarity with Programmable Logic Controllers (PLCs) and Human-Machine Interfaces (HMIs).

Compensation: The salary range for this position is $150,000.00 to $160,000.00 per year, depending on experience and qualifications.

Equal Opportunity Employer: Entegee is an equal opportunity employer, committed to diversity and inclusion in the workplace.

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