Associate Director, Facilities And Engineering

Position Summary

The Associate Director – Facilities and Engineering manages the engineering functions across facilities maintenance, validation processes, metrology programs, Asset Management, and Reliability-Centered Maintenance and Capital Projects within a pharmaceutical organization. You will oversee engineering teams, ensuring compliance with regulatory standards, managing complex projects, and enhancing operational efficiency through strategic plans, operational efficiency, and facility and equipment performance. At the same time, we are looking for a hands-on approach to project execution, with a focus on maintaining GMP (Good Manufacturing Practices) standards. You will report to the Senior Director of Facilities and Engineering.

Responsibilities

• Manage the maintenance and optimization of company facilities, including laboratories, production areas, and administrative spaces.
• Perform hands-on troubleshooting and repair of facility systems and equipment, ensuring compliance with health, safety, and environmental regulations.
• Oversee the daily operations of the facilities and engineering teams to ensure the efficient functioning of all building systems, including HVAC, electrical, plumbing, and utilities.
• Develop and implement preventive and predictive maintenance programs to maximize equipment uptime and reliability.
• Oversee routine and emergency maintenance activities, coordinating with our teams and external contractors.
• Provide hands-on technical support for engineering projects, including design, installation, and commissioning of systems and equipment.
• Implement and monitor preventive and predictive maintenance programs to enhance equipment reliability and performance.
• Troubleshoot and resolve engineering issues, ensuring systems operate and meet operational requirements.
• Lead validation activities for all equipment and processes, ensuring compliance with FDA and other regulatory requirements.
• Oversee and participate in hands-on validation activities for systems, equipment, and processes to ensure compliance with regulatory requirements (e.g., FDA, EMA).
• Review validation protocols and documentation, addressing any deviations or issues that arise.
• Coordinate with teams to ensure accurate validation outcomes.
• Develop validation master plans, protocols, and reports, and ensure execution of validation activities.
• Oversee the calibration and maintenance of all critical instruments and equipment, ensuring accuracy and compliance with industry standards.
• Manage hands-on metrology programs to ensure accuracy and reliability of measurement systems and instruments.
• Perform calibration and repair of measurement systems, ensuring compliance with industry standards and regulatory requirements.
• Conduct regular inspections and adjustments to maintain metrology standards.
• Lead capital projects, including facility upgrades, expansions, and new installations.
• Plan and implement capital projects from conception through completion, ensuring projects are delivered on time, within scope, and within budget.
• Collaborate with teams, including R&D, Quality, Manufacturing, and Supply Chain, to ensure understanding of project goals and timelines.
• Provide hands-on support in project planning, execution, and management, including installation, testing, and commissioning of new systems.
• Develop project documentation, budgets, and schedules, ensuring projects are completed on time, within budget, and to quality standards.
• Manage capital budgets, providing regular updates to senior management.
• Manage facility upgrades, renovations, and expansions to meet evolving our needs.
• Ensure compliance with all local, state, and federal regulations, including GMP and EHS (Environmental, Health, and Safety) standards.
• Develop and implement asset management strategies to maximize the value and lifespan of company assets.
• Perform hands-on tracking, maintenance, and optimization of assets, supporting the implementation of asset management processes.
• Analyze asset performance data and provide recommendations for improvements and corrective actions.
• Implement and lead reliability-centered maintenance programs to improve equipment reliability and performance.
• Use root cause analysis and techniques to find and address equipment failures.
• Develop and monitor goals to measure the effectiveness of maintenance programs and identify areas for improvement.
• Manage hands-on reliability-centered maintenance programs to improve equipment reliability and minimize downtime.
• Analyze maintenance data to identify trends and areas for improvement, implementing RCM practices to improve maintenance activities.
• Ensure execution of RCM strategies and address any issues or failures promptly.
• Prepare and maintain detailed documentation for validation, metrology, engineering, capital projects, asset management activities.
• Create regular reports on project status, maintenance activities, and asset performance, ensuring accuracy and compliance with regulatory requirements.
• Ensure all documentation meets internal and external standards.
• Ensure all activities comply with regulatory requirements, industry standards, and company policies.
• Develop safety protocols and emergency response plans, conducting regular safety audits and inspections.
• Address safety issues and ensure compliance with health, safety, and environmental regulations.
• Identify process improvements to enhance operational efficiency, reduce costs, and improve system reliability.
• Stay current with industry best practices and technological advancements, integrating solutions into operations.
• Foster a culture of continuous improvement within the team.
• Provide leadership, mentorship, and training to the facilities, engineering, validation, and metrology teams.
• Foster a culture of continuous improvement, teamwork, and accountability within the department.Qualifications:
• Bachelor's degree in Engineering, Facilities Management, or a related field; Master's degree or MBA preferred.
• 10+ years of hands-on experience in facilities management, engineering, validation, metrology, capital projects, asset management, and reliability-centered maintenance in a pharmaceutical or regulated industry.
• Experience managing complex projects and operations, with technical and practical skills.
• Knowledge of GMP, FDA regulations, and other relevant compliance requirements.
• Office and on-site facilities environment, with frequent hands-on work in laboratories, production areas, and maintenance sites.
• Occasional travel to multiple company sites or off-site locations.
• May require occasional evening or weekend work to address urgent issues or project needs.

The anticipated salary range for candidates who will work in Santa Monica, CA is $160,000 to $186,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

Note: At this time, Neogene is not sponsoring VISAs.

#LI-Onsite

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.