FUJIFILM Biotechnologies
Manager, Downstream Digital Operations
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
Job Title: Manager, Digital Operations
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.
Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the end of 2025 we’ll open North America’s largest end‑to‑end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill‑finish, and packaging under one roof. Located near Raleigh’s thriving tech scene, the site combines small‑town warmth with opportunities for growth. FUJIFILM is globally headquartered in Tokyo with over 70,000 employees across four key business segments. Visit https://www.fujifilm.com/us/en/about/region/careers for more.
What You’ll Do
Manage and develop the Digital Operations team for either Upstream, Downstream or Solution unit operations, providing guidance and ensuring effective performance management.
Oversee the selection, deployment, integration, and maintenance of digital tools (e.g., MES, data historians, e-logbooks).
Lead 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.
Establish clear objectives and expectations, conducting performance evaluations for team members.
Oversee configuration and approval, ensuring alignment with manufacturing requirements and regulatory standards.
Manage support activities for digital operations systems, maintaining consistency and reliability.
Own the development and delivery of training sessions and platforms for the Digital Operations team and other functional stakeholders.
Identify and implement solutions areas for process enhancement and efficiency within recipe‑driven automation.
Foster communication and collaboration between Digital Operations and other departments (e.g., Manufacturing, Automation, Quality, IT).
Promote innovation and adoption of best practices within digital operations.
Ensure all team activities comply with cGMP standards and regulatory requirements.
Implement quality assurance measures to maintain data and record integrity.
Foster effective communication between the Digital Operations team and other departments (e.g., MFG, Automation, Quality, FLBD).
Promote cross‑functional collaboration to support digital integration in manufacturing processes.
Manage Digital Support on‑call support including scheduling and on‑call issue review.
Manage and develop direct reports from the Digital Operations team.
Administer company policies such as time off, shift work, and inclement weather that directly impact employees.
Complete required administrative tasks (e.g., timecard approvals, time off approvals, expense reports).
Coach and guide direct reports to foster professional development.
Participate in the recruitment process and retention strategies to attract and retain talent, as needed.
Address performance gaps, employee questions and concerns, and partner with HR as needed for resolution.
Perform other duties as assigned.
Basic Requirements
High school diploma with 8+ years of experience, or
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.
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.
Preferred Requirements
6‑10 years’ experience in pharmaceutical/biological manufacturing operations.
Experience 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).
Working Conditions & Physical Requirements
Ability to discern audible cues.
Ability to stand for prolonged periods of time.
Ability to sit for prolonged periods of time.
Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
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Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the end of 2025 we’ll open North America’s largest end‑to‑end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill‑finish, and packaging under one roof. Located near Raleigh’s thriving tech scene, the site combines small‑town warmth with opportunities for growth. FUJIFILM is globally headquartered in Tokyo with over 70,000 employees across four key business segments. Visit https://www.fujifilm.com/us/en/about/region/careers for more.
What You’ll Do
Manage and develop the Digital Operations team for either Upstream, Downstream or Solution unit operations, providing guidance and ensuring effective performance management.
Oversee the selection, deployment, integration, and maintenance of digital tools (e.g., MES, data historians, e-logbooks).
Lead 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.
Establish clear objectives and expectations, conducting performance evaluations for team members.
Oversee configuration and approval, ensuring alignment with manufacturing requirements and regulatory standards.
Manage support activities for digital operations systems, maintaining consistency and reliability.
Own the development and delivery of training sessions and platforms for the Digital Operations team and other functional stakeholders.
Identify and implement solutions areas for process enhancement and efficiency within recipe‑driven automation.
Foster communication and collaboration between Digital Operations and other departments (e.g., Manufacturing, Automation, Quality, IT).
Promote innovation and adoption of best practices within digital operations.
Ensure all team activities comply with cGMP standards and regulatory requirements.
Implement quality assurance measures to maintain data and record integrity.
Foster effective communication between the Digital Operations team and other departments (e.g., MFG, Automation, Quality, FLBD).
Promote cross‑functional collaboration to support digital integration in manufacturing processes.
Manage Digital Support on‑call support including scheduling and on‑call issue review.
Manage and develop direct reports from the Digital Operations team.
Administer company policies such as time off, shift work, and inclement weather that directly impact employees.
Complete required administrative tasks (e.g., timecard approvals, time off approvals, expense reports).
Coach and guide direct reports to foster professional development.
Participate in the recruitment process and retention strategies to attract and retain talent, as needed.
Address performance gaps, employee questions and concerns, and partner with HR as needed for resolution.
Perform other duties as assigned.
Basic Requirements
High school diploma with 8+ years of experience, or
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.
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.
Preferred Requirements
6‑10 years’ experience in pharmaceutical/biological manufacturing operations.
Experience 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).
Working Conditions & Physical Requirements
Ability to discern audible cues.
Ability to stand for prolonged periods of time.
Ability to sit for prolonged periods of time.
Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
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