Director Engineering Facilities and Reliability - Entegee

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.