Director of Engineering
14 hours ago
Philadelphia
Director of Engineering Be part of something bigger—where every role contributes to creating hope for patients around the world. In this organization, breakthrough science is transformed into real-world therapies that change lives. Team members across global locations collaborate to bring innovative cell and gene therapies from concept to commercialization. You’ll join a purpose-driven environment focused on innovation, collaboration, and patient impact. Whether working in the lab, cleanroom, or supporting operations, your contributions will directly enable life-saving treatments and make a lasting difference. If you’re passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, this is an opportunity to help shape the future of medicine—one patient at a time. Position Summary Responsible for directing all facilities functions to ensure operational business units are supplied with the necessary physical infrastructure to meet organizational objectives, including facility maintenance, engineering, and metrology. Key responsibilities include preventative maintenance of facilities and systems, monitoring and calibration, managing engineering change control, troubleshooting equipment and processes, maintaining up-to-date as-built engineering drawings and Validation Master Plan, managing external contractors, and supervising a Facilities team operating within current Good Manufacturing Practices (cGMP) and cleanroom standards. This role also collaborates with internal departments, vendors, and commercial partners, assesses facility fit for incoming programs, and establishes operational structures to support multi-shift operations. Additionally, the position oversees metrology services during start-up, commissioning, validation, and capital improvements of multi-product manufacturing and testing facilities. Essential Functions and Responsibilities • Direct Facilities and Metrology services, • Develop budget projections, material plans, and staffing forecasts, • Develop SOPs, test reports, out-of-tolerance notifications, and validation protocols, • Establish calibration schedules aligned with business and customer goals, • Implement preventative maintenance forecasting with continuous improvement, • Maintain personnel policies, procedures, and production control systems, • Ensure all facility equipment is maintained, calibrated, qualified, and/or validated, • Evaluate new production procedures and technologies, • Conduct failure analysis, root cause investigations, and corrective actions, • Update as-built drawings as required, • Optimize use of equipment, facilities, and personnel for efficiency, • Recommend process and operational improvements, • Lead capital improvement projects, • Plan facility organizational structure to support growth and site master planning, • Generate maintenance, engineering, and metrology performance summaries, • Develop and implement effective staff training programs, • Communicate routine and non-routine updates to leadership and stakeholders, • Lead investigations related to deviations and out-of-tolerance conditions, • Manage contractors for construction, renovation, and validation activities, • Coordinate with suppliers and vendors, • Contribute to strategic planning with senior leadership, • Manage team performance, coaching, and development, • Support flexible operations, including off-hours support when required, • Perform additional duties as needed Knowledge, Skills & Abilities • Strong leadership and team management capabilities, • Deep understanding of regulatory compliance for biologics manufacturing, • Knowledge of contract manufacturing operations and business needs, • High mechanical and technical aptitude, • Excellent written and verbal communication skills, • Ability to interpret and communicate complex technical information, • Strong analytical and problem-solving abilities, • Experience evaluating technical data and producing documentation, • Sound decision-making skills in complex environments, • Ability to work collaboratively and independently, • Strong attention to detail and data accuracy Education & Experience • Bachelor’s degree in a technical discipline (Mechanical, Electrical, Chemical Engineering, or related field), • Minimum of 10 years of engineering experience, • Minimum of 5 years of supervisory experience in a related technical field, • At least 5 years of experience in a cGMP life sciences environment Leadership Responsibilities • Promote a diverse and inclusive workplace culture, • Ensure compliance with all applicable laws, regulations, and internal policies, • Recruit, develop, and retain high-performing talent, • Set performance expectations and drive employee engagement, • Support career development and organizational growth, • Build strong customer relationships and deliver customer-focused solutions, • Maintain transparent and effective communication across teams, • Adapt to changing priorities and ambiguous environments, • Uphold the highest ethical standards and confidentiality, • Demonstrate strong autonomy and decision-making capability Quality Requirements • Ensure compliance with FDA and global quality and regulatory standards, • Follow established procedures and protocols, • Maintain a strong focus on continuous training and development, • Uphold data integrity and accuracy across all responsibilities, • Support operational excellence through adherence to quality systems