Senior Director, Facilities & Engineering

The Senior Director, Facilities and Engineering is responsible for the building and equipment and system performance of a cGMP manufacturing facility. The Senior Director leads, manages, and coaches engineering, validation, maintenance, and capital project staff to ensure equipment and systems are designed, installed, and consistently perform as intended when needed. They develop an engaged, high‑performing team that demonstrates KBI core values with a culture of safety and quality. The Senior Director develops strategies, processes, systems, procedures, and metrics to achieve a high level of facility and equipment availability, reliability, and performance. They monitor equipment work orders, change controls, qualification status, and readiness, and manage facility and engineering processes associated with new product introductions. The Senior Director is responsible for developing and implementing strategies, methods, and procedures for new and existing facilities and equipment, ensuring alignment and coordination with other site functions such as Finance, Manufacturing, MS&T, QC Analytical/Laboratories, and Quality Assurance. They lead efforts across functional boundaries, work with peers in a matrixed organization, represent the functional area to clients, auditors, and inspectors, and oversee engineering support for multiple systems, processes, or areas. The Senior Director applies advanced approaches to develop and implement strategies, technologies, or other major improvements, directs, reviews, and approves engineering documents, and supports monthly reports covering overall status, key issues, and performance KPIs. Responsibilities Direct engineering, validation, capital project, and maintenance activities for the site. Oversee corrective and preventative maintenance and repair of facilities, utilities, and equipment. Direct implementation of improvements to reduce failures and errors. Oversee multiple capital projects and operational improvement projects, DEVs, CAPAs, and/or Change Controls while ensuring their success in meeting their respective objectives. Represent the Facilities & Engineering activities during client audits and regulatory inspections. Ensure engineering, maintenance, and calibration procedures and systems are in a state of compliance and control. Establish and maintain a system of metrics and reporting to evaluate the effectiveness of facility and maintenance activities. Manage employment, employee motivation, counseling, discipline, and changes in status of employees supervised. Lead team building, organizational development, and training; plan and execute strategies to drive improvements and achieve objectives and goals. Responsible for resource planning and performance management, including coaching, mentoring, and discipline. Qualifications Minimum of a Bachelor’s degree in an engineering discipline (mechanical, electrical, chemical, biomechanical). Minimum 15 years of engineering experience, with at least 10 years in the biotech industry and 5 years in management. Established expertise and knowledge of biopharmaceutical manufacturing, good engineering practices, and equipment design and qualification. Strong technical writing and communication skills. Negotiation skills and ability to drive resolution on critical issues. Ability to summarize complex issues and present to executive management. Broad understanding of applicable codes and in‑depth working knowledge of cGMP requirements and regulations. Demonstrated track record in the following key areas: Strong orientation for quality and customer service High level of integrity and personal responsibility Communication skills within all levels of an organization Ability to align growth requirements and profit objectives Risk assessment and risk management Project management including project delivery under aggressive timelines Staff development and coaching KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. Any employee entering a KBI site located in the U.S. must inform KBI Biopharma of their vaccination status and submit proof of COVID‑19 vaccination (FDA approved or under Emergency Use Authorization). All vaccinated employees are required to provide proof of their vaccination status. #J-18808-Ljbffr KBI Biopharma, Inc.