Director, Operational Technology

Unither Pharmaceuticals

1d • Onsite

About The Position

You're excited to be counted on as a leader within our Operational Technology group while still being ready and willing to roll up your sleeves and get hands-on at a moments notice. The Director, Operational Technology will provide strategic leadership and management of Operational Technology professionals supporting manufacturing, automation, and quality systems within a regulated, validated environment. This role will lead and develop a multidisciplinary team of professional and support staff, fostering technical excellence, continuous improvement, and a strong culture of accountability and collaboration. The Director will execute the OT vision and roadmap, ensuring reliable, compliant, and scalable technology solutions across manufacturing, quality, and manufacturing support platforms. They will partner closely with cross-functional stakeholders—including Manufacturing, Quality, Engineering, IT, and Business Leadership—to align technology strategy with enterprise objectives and enable operational growth. This position will be responsible for setting priorities, allocating resources, and managing execution across multiple initiatives while balancing day-to-day operational support with short- to medium-term strategic planning. The Director will drive standardization, innovation, and risk-based decision-making, ensuring systems meet regulatory requirements while advancing automation, data integration, and digital transformation initiatives.

Requirements

• Bachelor’s Degree in Information Technology, Chemical Engineering or BioEngineering or an applicable scientific and/or engineering discipline preferred, will consider commensurate experience and/or combination of education and experience
• 15+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on SAP, Laboratory Information Management Systems (LIMS) systems, Chromatography Data Systems, Electronic Lab Notebooks (ELN), and/or Enterprise Document Management (EDM) systems
• 8+ years of people management experience
• Strong people leadership and management expertise, and demonstrated competency in the management of complex staff and organizational issues
• General management administrative skills (budgeting, resource allocation, etc.)
• Excellent project management skills
• Effective leadership, and strong verbal, presentation, and technical writing skills
• Superior database maintenance / development experience
• Computer hardware / software validation and change control experience
• Ability to interface with external and internal resources at all levels
• Broad knowledge of the regulatory requirements for pharmaceutical applications
• Working skills and experience with PLCs, DCSs, Batch Operations (S88/S95), SCADA, MRP, IT, and OEM equipment
• Experience in the design, implementation, and maintenance of large-scale information systems (MRP, MES, LIMS) to support regulated FDA pharmaceutical manufacturing operations
• A broad knowledge and practical experience of computer, equipment, and application validation (GAMP methodology), cGMPs, and 21 CFR Part 11

Nice To Haves

• Certified Project Management Professional (PMP)-PMI

Responsibilities

• Lead, guide, and develop the Operational Technology (OT) team, including but not limited to mentoring, setting goals, supporting career development, and providing ongoing training
• Build and maintain a highly motivated team of engineers and technicians to ensure optimum technical support for manufacturing and quality systems
• Provide oversight of OT projects, monitor progress, manage resources, and maintain timelines
• Manage engineers, technicians and external contractors during system development, fabrication, installation, and start-up activities
• Provide strategic and tactical management guidance as a key liaison between Manufacturing, Quality and Management in relation to process automation and information technology systems
• Develop, implement and drive OT departmental and interdepartmental strategic objectives
• Provide multi-site resource and system administration/management including Research Triangle Park, Silver Spring, Beltsville, and other identified strategic sites
• Perform troubleshooting of challenging equipment / automation issues to improve manufacturing performance and maintenance of the automation systems in compliance with cGMPs
• Provide technical input, as required, for regulatory submissions and agency queries
• Ensure plant preventive maintenance, metrology, security and programs are functioning effectively and meet regulatory and outside agency compliance requirements
• Evaluate and recommend software, hardware, and vendors. Conduct vendor audits as required.
• Establish and manage adherence to departmental budgets, schedules, work plans and performance requirements through effective measurement tools

Benefits

• Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
• For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees