Manager, Upstream Digital Operations

Fujifilm•Holly Springs, NC

About The Position

The Manager, Digital Operations oversees the management and optimization of digital tools such as Manufacturing Execution Systems (MES), data historians, and e-logbooks within Drug Substance Manufacturing. This role involves strategic configuration, approval, and support of recipe-driven operations across one family unit operations (e.g., Upstream, Downstream, or Solutions). The Manager, Digital Operations drives continuous improvement of digital solutions by ensuring alignment with manufacturing processes, integration standards, and stringent regulatory requirements. The Manager, Digital Operations plays a crucial role in the tech transfer process, identifying platform capability gaps to meet new client needs. This role collaborates extensively with cross-functional teams to facilitate seamless digital integration and operational excellence with a focus on promoting digital innovation and enhancing data integrity.

Requirements

High school diploma with 8+ years of experience
Associate’s degree with 6+ years of experience; OR
Bachelor’s degree with 4+ years of experience; OR
Master’s degree with 2+ years of experience; OR
Experience directly supporting manufacturing and managing cross-functional initiatives in a manufacturing setting
2-5 years of people management experience
Experience working in a changing, project driven organization

Nice To Haves

6-10 years’ experience in pharmaceutical / biological manufacturing operations
Experience in in manufacturing of biological products, familiar with GMP/GLP requirements.
Previous experience leading, supervising or managing others
Experience implementing and supporting digital manufacturing systems (e.g., MES, PI data historian, automation/DCS/PLC, LIMS, ERP integration)

Responsibilities

Manages and develops the Digital Operations team for either Upstream, Downstream or Solution unit operations, providing guidance and ensuring effective performance management
Oversees the selection, deployment, integration, and maintenance of digital tools (e.g., MES, data historians, e-logbooks)
Leads the identification and implementation of solutions to address capability gaps in digital operations, ensuring alignment with new product and client requirements within the RDO process
Establishes clear objectives and expectations, conducting performance evaluations for team members
Oversees configuration and approval, ensuring alignment with manufacturing requirements and regulatory standards
Manages support activities for digital operations systems, maintaining consistency and reliability
Owns the development and delivery of training sessions and platforms for the Digital Operations team and other functional stakeholders
Identifies and implements solutions areas for process enhancement and efficiency within recipe-driven automation
Fosters communication and collaboration between Digital Operations and other departments (e.g., Manufacturing, Automation, Quality, IT)
Promotes innovation and adoption of best practices within digital operations
Ensures all team activities comply with cGMP standards and regulatory requirements
Implement quality assurance measures to maintain data and record integrity
Fosters effective communication between the Digital Operations team and other departments (e.g., MFG, Automation, Quality, FLBD)
Promotes cross-functional collaboration to support digital integration in manufacturing processes
Manages Digital Support on-call support including scheduling and on-call issue review
Manages and develops direct reports from the Digital Operations team
Administers company policies such as time off, shift work, and inclement weather that directly impact employees
Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
Coaches and guides direct reports to foster professional development
Participates in the recruitment process and retention strategies to attract and retain talent, as needed
Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
Performs other duties, as assigned