Key Responsibilities:

Facility Maintenance and Operations:

• Manage the operation and upkeep of manufacturing and equipment facility systems, including HVAC, electrical, plumbing, Reverse Osmosis DI Water system, and process utilities.
• Develop and implement programs for equipment calibration and preventive maintenance.
• Perform routine maintenance and repairs on pharmaceutical equipment.

Compliance and Regulatory:

• Ensure the facility adheres to all FDA, DEA, and other regulatory requirements.
• Prepare for and participate in regulatory inspections and audits, ensuring documentation and records are accurate and compliant.
• Support Quality Assurance by implementing corrective actions and driving continuous improvement initiatives.

Project Management:

• Lead and manage facility-related projects, such as upgrades, expansions, and new installations.
• Collaborate with contractors, vendors, and internal teams to ensure projects are completed on schedule, within budget, and meet required specifications.

Safety and Environmental Management:

• Ensure all facility operations comply with safety regulations and best practices.
• Conduct regular safety training sessions, inspections, and risk assessments.
• Oversee waste management and ensure environmental compliance.

Documentation and Reporting:

• Maintain comprehensive records of maintenance activities, equipment inspections, and compliance audits.
• Generate and submit regular reports on facility operations, maintenance, and compliance to management.

Team Leadership and Training:

• Supervise and mentor junior facility staff, providing training and development opportunities.
• Promote a culture of continuous improvement, safety, and compliance within the facilities team.

Qualifications:

Education and Experience:

• Bachelor’s degree in Engineering, Facilities Management, or a related field.
• At least 5 years of experience in facility engineering, specifically in pharmaceutical maintenance, air handling systems, differential pressure management, and air particle testing.

Technical Skills:

• Strong understanding of cGMP regulations and DEA requirements.
• Proficiency in environmental control and facility systems, including HVAC, electrical, plumbing, and process utilities.
• Experience with computerized maintenance management systems (CMMS) and building management systems (BMS).
• General knowledge of pharmaceutical equipment maintenance.