Neogene Therapeutics
Director, Facilities and Engineering
Neogene Therapeutics, California, Missouri, United States, 65018
Position Summary
The Director of Facilities and Engineering provides strategic leadership and oversight across all of these critical functions within a pharmaceutical organization. You will ensure the regulatory compliance, and strategic understanding of facilities maintenance, validation processes, metrology programs, engineering operations, capital projects, asset management, and reliability-centered maintenance.
Responsibilities
Lead teams across facilities, validation, metrology, engineering, capital projects, asset management, and reliability-centered maintenance.
Develop and implement strategic goals and programs that align with organizational goals.
Mentor and support team members to foster professional growth.
Oversee the maintenance, operation, and optimization of company facilities, including laboratories, production areas, and administrative spaces.
Ensure facilities comply with health, safety, and environmental regulations.
Develop facility improvement and expansion plans.
Direct the development of validation strategies, protocols, and documentation for systems, equipment, and processes.
Ensure validation activities meet regulatory requirements (e.g., FDA, EMA) and internal standards.
Oversee complex validation projects and ensure documentation and reporting.
Lead the development of metrology programs to ensure the accuracy and reliability of measurement systems and instruments.
Develop calibration, maintenance, and inspection programs for critical equipment.
Ensure metrology practices comply with industry standards and regulatory requirements.
Oversee engineering projects related to the design, installation, and commissioning of systems and equipment.
Ensure engineering activities follow Good Manufacturing Practices (GMP) and other relevant regulations.
Manage preventive and predictive maintenance programs to enhance equipment reliability.
Manage all aspects of capital projects, including facility upgrades, expansions, and new construction.
Develop project plans, budgets, and schedules; monitor progress to ensure projects are completed on time, within budget, and to quality standards.
Coordinate with team members, external contractors, and vendors to achieve project goals and ensure compliance.
Develop and implement asset management strategies to maximize the value and lifespan of company assets.
Oversee the tracking, maintenance, and optimization of assets to compliance.
Implement asset management processes to support strategic decision-making.
Develop and oversee reliability-centered maintenance programs to improve equipment reliability and minimize downtime.
Implement RCM strategies and practices to improve maintenance activities and enhance operational performance.
Analyze data to identify failure trends and implement corrective actions to prevent recurrence.
Manage annual budgets for facilities, validation, metrology, engineering, capital projects, asset management, and RCM.
Monitor expenses, identify cost-saving opportunities, and ensure allocation of resources.
Provide financial reporting to senior management.
Ensure all facilities and systems comply with regulatory requirements and industry standards.
Develop safety protocols and emergency response plans.
Conduct regular audits and inspections to maintain compliance and address any issues promptly.
Identify process improvements to enhance efficiency, reduce costs, and improve system reliability.
Promote and integrate solutions and sustainable practices in facilities management, validation, engineering, and maintenance activities.
Education and Experience
Bachelor's degree in Engineering, Facilities Management, or a related field; Master's degree.
10+ years of experience in facilities management, validation, metrology, engineering, capital projects, asset management, and reliability-centered maintenance, with significant experience in a pharmaceutical or regulated industry.
Experience managing complex projects and operations, with knowledge of GMP, FDA regulations, and other relevant compliance requirements.
When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base salary for this position ranges from $147K to $184K. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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.
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The Director of Facilities and Engineering provides strategic leadership and oversight across all of these critical functions within a pharmaceutical organization. You will ensure the regulatory compliance, and strategic understanding of facilities maintenance, validation processes, metrology programs, engineering operations, capital projects, asset management, and reliability-centered maintenance.
Responsibilities
Lead teams across facilities, validation, metrology, engineering, capital projects, asset management, and reliability-centered maintenance.
Develop and implement strategic goals and programs that align with organizational goals.
Mentor and support team members to foster professional growth.
Oversee the maintenance, operation, and optimization of company facilities, including laboratories, production areas, and administrative spaces.
Ensure facilities comply with health, safety, and environmental regulations.
Develop facility improvement and expansion plans.
Direct the development of validation strategies, protocols, and documentation for systems, equipment, and processes.
Ensure validation activities meet regulatory requirements (e.g., FDA, EMA) and internal standards.
Oversee complex validation projects and ensure documentation and reporting.
Lead the development of metrology programs to ensure the accuracy and reliability of measurement systems and instruments.
Develop calibration, maintenance, and inspection programs for critical equipment.
Ensure metrology practices comply with industry standards and regulatory requirements.
Oversee engineering projects related to the design, installation, and commissioning of systems and equipment.
Ensure engineering activities follow Good Manufacturing Practices (GMP) and other relevant regulations.
Manage preventive and predictive maintenance programs to enhance equipment reliability.
Manage all aspects of capital projects, including facility upgrades, expansions, and new construction.
Develop project plans, budgets, and schedules; monitor progress to ensure projects are completed on time, within budget, and to quality standards.
Coordinate with team members, external contractors, and vendors to achieve project goals and ensure compliance.
Develop and implement asset management strategies to maximize the value and lifespan of company assets.
Oversee the tracking, maintenance, and optimization of assets to compliance.
Implement asset management processes to support strategic decision-making.
Develop and oversee reliability-centered maintenance programs to improve equipment reliability and minimize downtime.
Implement RCM strategies and practices to improve maintenance activities and enhance operational performance.
Analyze data to identify failure trends and implement corrective actions to prevent recurrence.
Manage annual budgets for facilities, validation, metrology, engineering, capital projects, asset management, and RCM.
Monitor expenses, identify cost-saving opportunities, and ensure allocation of resources.
Provide financial reporting to senior management.
Ensure all facilities and systems comply with regulatory requirements and industry standards.
Develop safety protocols and emergency response plans.
Conduct regular audits and inspections to maintain compliance and address any issues promptly.
Identify process improvements to enhance efficiency, reduce costs, and improve system reliability.
Promote and integrate solutions and sustainable practices in facilities management, validation, engineering, and maintenance activities.
Education and Experience
Bachelor's degree in Engineering, Facilities Management, or a related field; Master's degree.
10+ years of experience in facilities management, validation, metrology, engineering, capital projects, asset management, and reliability-centered maintenance, with significant experience in a pharmaceutical or regulated industry.
Experience managing complex projects and operations, with knowledge of GMP, FDA regulations, and other relevant compliance requirements.
When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base salary for this position ranges from $147K to $184K. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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.
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