Manager, Upstream Digital Operations

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

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 end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll Do

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

Basic Requirements

High school diploma with 8 years of experience
Associates degree with 6 years of experience; OR
Bachelors degree with 4 years of experience; OR
Masters 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

Preferred Requirements

6-10 years experience in pharmaceutical / biological manufacturingoperations
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)

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

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto 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 ().

Required Experience:

Manager

Position OverviewThe 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...