Sr. Director, Engineering, Validation & Maintenance

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Sr. Director, Engineering, Validation and Maintenance is responsible for the strategic leadership, development, and execution of engineering, validation, maintenance, reliability, and manufacturing automation programs that support current operations and future growth of the site. This role provides end-to-end lifecycle ownership of facility, utility, manufacturing, laboratory, and automation systems, ensuring regulatory compliance, operational excellence, asset reliability, and business continuity. The Sr. Director leads all aspects of engineering, including capital project planning and execution, facility and utility design, equipment procurement, installation, commissioning, and lifecycle management. The role oversees validation activities, including commissioning, qualification (IQ/OQ/PQ), computerized system validation, and ongoing requalification programs. Additionally, the position is responsible for site maintenance, metrology, and reliability engineering programs focused on maximizing equipment uptime, optimizing asset performance, reducing operational risk, and implementing predictive and reliability-centered maintenance strategies. The role also provides leadership for manufacturing automation and digital infrastructure, including process control systems, SCADA, PLCs, manufacturing data systems, historian platforms, and computerized systems that support GMP manufacturing operations. The Sr. Director drives automation and digital transformation initiatives that improve process robustness, data integrity, operational efficiency, and manufacturing scalability. As a key member of the site leadership team, the Sr. Director develops and executes long-range capital and infrastructure strategies while ensuring facility, utility, contamination control, and automation systems remain aligned with current regulatory expectations and business objectives. The position serves as a technical leader during client interactions, regulatory inspections, and corporate initiatives, while building organizational capability through talent development, succession planning, and continuous improvement. This role fosters a culture of safety, quality, compliance, reliability, innovation, and operational excellence by leveraging modern engineering practices, Lean principles, risk-based decision-making, and cross-functional collaboration to support the successful delivery of sterile pharmaceutical manufacturing operations. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Leadership, Strategy, and Organizational Development Develop, implement, and continuously improve site engineering, validation, maintenance, metrology, reliability, and automation strategies that support current operations, future growth, compliance, and operational excellence objectives. Establish departmental goals, key performance indicators (KPIs), and long-range strategic plans aligned with business objectives and network standards. Build, develop, and retain a high-performing technical organization through effective leadership, coaching, mentoring, succession planning, and talent development. Foster a culture of safety, quality, accountability, innovation, operational excellence, and continuous improvement. Represent the department on site leadership teams, governance forums, client meetings, audits, inspections, and cross-functional initiatives. Develop and manage departmental operating budgets and long-range capital investment plans. Engineering and Technical Operations Provide strategic and technical leadership for facility, utility, manufacturing, laboratory, and process support systems throughout the asset lifecycle. Oversee engineering activities including conceptual design, scope development, budgeting, procurement, construction management, installation, commissioning, startup, and lifecycle management. Ensure equipment, facility, utility, and automation systems are designed, maintained, and operated in accordance with cGMP, regulatory requirements, corporate standards, and industry best practices. Serve as the site subject matter expert (SME) for facility infrastructure, clean utilities, process equipment, contamination control systems, and critical GMP support systems. Support sterile manufacturing operations through effective management of engineering resources and technical problem-solving. Validation and Compliance Oversee facility, utility, equipment, process, and computerized system validation programs. Ensure execution of commissioning, qualification, and validation activities including FAT, SAT, IQ, OQ, PQ, requalification, and periodic review programs. Partner with Quality to maintain compliant validation systems aligned with cGMP, FDA, EMA, ICH, ISPE, and corporate requirements. Support internal audits, customer audits, and regulatory inspections while ensuring timely completion of commitments and corrective actions. Drive continuous improvement of validation lifecycle management and risk-based qualification practices. Reliability Engineering and Asset Management Establish and maintain a Reliability Engineering program focused on maximizing equipment availability, minimizing downtime, and reducing lifecycle costs. Develop and monitor key reliability metrics including equipment uptime, schedule compliance, and asset utilization. Assist with root cause investigations and corrective actions related to equipment failures, recurring deviations, and operational losses. Drive asset lifecycle management strategies to optimize performance, reliability, maintainability, and regulatory compliance. Maint