Director, Facilities Engineering

Position Overview:

Cartesian Therapeutics is reimagining Cell Therapies with promising breakthroughs to help patients with autoimmune diseases. We are seeking an innovative and experienced Director of Facilities and Engineering to provide strategic leadership for departmental functions, including managing, planning, directing, and evaluating operations related to facilities maintenance, validation and metrology, engineering operations, capital project management, asset management, and reliability-centered maintenance. This role is critical to ensuring optimal performance and compliance across all facilities and engineering initiatives.

Key Responsibilities:

• Strategic Leadership: Drive regulatory compliance and foster a strategic understanding of facilities maintenance, validation processes, metrology programs, engineering operations, capital projects, asset management, and reliability-centered maintenance.
• Team Leadership: Lead and mentor teams across facilities, validation, metrology, engineering, capital projects, asset management, and reliability-centered maintenance to achieve departmental and organizational objectives.
• Goal Development: Develop and implement strategic goals and programs that align with the organization's vision and milestones.
• Professional Growth: Mentor and support team members, fostering an environment conducive to professional development.
• Facilities Oversight: Oversee the maintenance, operation, and optimization of company facilities, including laboratories, production areas, and administrative spaces, ensuring compliance with health, safety, and environmental regulations.
• Improvement Planning: Develop comprehensive facility improvement and expansion plans that align with strategic initiatives.
• Validation Management: Direct the development of validation strategies, protocols, and documentation for systems, equipment, and processes, ensuring compliance with regulatory requirements (e.g., FDA, EMA) and internal standards.
• Project Oversight: Manage complex validation projects, ensuring thorough documentation and reporting.
• Metrology Programs: Lead the development of metrology programs to guarantee the accuracy and reliability of measurement systems and instruments, ensuring compliance with industry standards and regulatory requirements.
• Engineering Projects: Oversee engineering projects related to the design, installation, and commissioning of systems and equipment, ensuring adherence to Good Manufacturing Practices (GMP) and relevant regulations.
• Maintenance Programs: Manage preventive and predictive maintenance programs aimed at enhancing equipment reliability.
• Capital Project Management: Manage all aspects of capital projects, including facility upgrades, expansions, and new constructions. Develop project plans, budgets, and schedules while monitoring progress to ensure timely, on-budget, and high-quality completion.
• Collaboration: Coordinate with team members, external contractors, and vendors to achieve project goals and ensure compliance.
• Asset Management: Develop and implement asset management strategies to maximize the value and lifespan of company assets, including tracking, maintenance, and optimization processes.
• Reliability-Centered Maintenance: Develop and oversee reliability-centered maintenance programs to improve equipment reliability and minimize downtime through effective RCM strategies.
• Data Analysis: Analyze data to identify failure trends, implementing corrective actions to prevent recurrence.
• Budget Management: Manage annual budgets for facilities, validation, metrology, engineering, capital projects, asset management, and RCM, monitoring expenses and identifying cost-saving opportunities.
• Regulatory Compliance: Ensure all facilities and systems comply with regulatory requirements and industry standards. Develop safety protocols and emergency response plans, conducting regular audits and inspections.
• Process Improvement: Identify process improvements to enhance efficiency, reduce costs, and improve system reliability. Promote and integrate sustainable practices in facilities management, validation, engineering, and maintenance activities.

Education and Experience:

• Bachelor's degree in Engineering, Facilities Management, or a related field, or equivalent experience.
• 10+ years of experience in facilities management, validation, metrology, engineering, capital projects, asset management, and reliability-centered maintenance, with significant experience in a pharmaceutical, biotech, or similarly regulated industry.
• Proven experience managing complex projects and operations, with extensive knowledge of GMP, FDA regulations, and other relevant compliance requirements.

Cartesian is an Equal Opportunity Employer and is committed to fostering an environment in which all employees are treated fairly without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, ancestry, disability, marital status, genetic information, military status, or any other characteristic protected under applicable law.