United Therapeutics Corporation · 10 hours ago
Director, Operational Technology
Triangle Area
Full-time
Onsite
Director/Executive
15+ years expUnited Therapeutics Corporation is a pioneering biotech company focused on developing innovative therapies and technologies for transplantable organs. The Director of Operational Technology will lead a multidisciplinary team to manage and enhance operational technology systems within a regulated environment, ensuring compliance and driving technological advancements across manufacturing and quality systems.
BiotechnologyPharmaceuticalTherapeutics
Hiring Manager
William Neutzling
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
Qualification
Required
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
Preferred
Certified Project Management Professional (PMP)-PMI
Benefits
Medical / dental / vision / prescription coverage
Employee wellness resources
Savings plans (401k and ESPP)
Paid time off & paid parental leave benefits
Disability benefits
More
Company
United Therapeutics Corporation
Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions.
1001-5000 employees
H1B Sponsorship
United Therapeutics Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (13)
2023 (8)
2022 (6)
2021 (9)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
unknown1999-06-17IPO
Leadership Team
Hamlet Bonilla Evertsz
Senior Network Engineer
Recent News
2026-01-09
2025-12-29
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