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

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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.