Chief Reliability Officer
6 days ago
Job Title: Chief Reliability Officer - Engineering and Facilities
">About Us: Entegee is a leading provider of custom automation projects, specializing in controls and robotic solutions worldwide.
">Estimated Salary Range: $150,000.00 to $160,000.00 per year
">Job Description:
">- 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:
">- 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:
">- 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).
About the Role:
">This is a unique opportunity to join a dynamic team and contribute to the success of our organization.
">We are committed to equal opportunities and welcome applications from diverse candidates.
">To learn more about our company culture and values, please visit our website at 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.
">EOE/Veterans/Disabled
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