Engineering Documentation Specialist

FUJIFILM; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an Engineering Documentation Specialist to manage engineering turnover documentation in a paperless environment. You will own document control through EDMS, maintain SOPs, support BIM and IT integration, and ensure audit readiness across projects.

The role requires strong attention to data integrity, experience with GMP-related documentation, and ability to train users on the electronic document management system.

Qualifications

• Experience with GMP document control in biopharma preferred.
• Proven ability to manage complex document workflows.
• Strong understanding of EDMS and SOPs in a GMP setting.

Responsibilities

• Organizes, compiles, and maintains engineering & facility documents.
• Manages approval workflows and ensures data integrity and audit readiness.
• Maintains SOPs and enforces document control procedures across teams.
• Handles transmittals and defines submittal standards.
• Collaborates with external Document Controllers and IT for EDMS.
• Provides training and technical guidance on EDMS to stakeholders.

Skills

Document management

EDMS

SOP enforcement

Transmittals

BIM support

EDMS training

Education

High School Diploma

Associate's degree

Bachelor's degree

Tools

EDMS

Job description

Position Overview

The Engineering Documentation Specialist demonstrates complete and thorough understanding of Engineering turnover documentation and is responsiblefor day-to-day document management activities in a paperless environment. This role processes incoming and outgoing documents, including receipt,classification, registry, distribution, archive, storage, and retrieval. This role also serves as the administrator for project documentation management systemand the subject matter expert (SME) for Good Manufacturing Practice (GMP) Engineering Management system.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By 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.

We’re 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 we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do:

• Organizes, compiles, and maintains engineering and facility documentation (e.g., equipment documentation, facility drawings, specifications, etc.)
• Maintains documentation for existing equipment and manages approval workflows ensuring data integrity and audit readiness
• Processes project related documentation and turnover packages to ensure completeness, traceability, and seamless transition to operations
• Maintains departmental standard operating procedures (SOPs), monitors adherence across project teams, and enforces approved document control procedures
• Manages transmittals and issues to external stakeholders – and defining submittal protocols and standards (e.g., naming conventions, etc.)
• Collaborates with external Document Controllers ensuring compliance to established policies and procedures
• Identifies opportunities to enhance document control processes and right-first-time quality
• Integrates project management and quality principles within the document control function
• Assists the Building Information Modeling (BIM) team with documentation, including model/drawing standards and execution plans
• Partners with IT to configure, update, and sustain Electronic Document Management System (EDMS)
• Delivers training and user enablement for all EDMS and provides technical guidance to stakeholders, as needed
• Performs other duties, as assigned

Minimum Requirements:

• High School Diploma or GED with 9 years of document managementexperience (5 in the biopharmaceutical industry); or
• Associate’s degree in engineering or related field with 7 years of document management experience (5 in the biopharmaceutical industry); or
• Bachelor’s degree in engineering or related field with 5 years of document management experience in the biopharmaceutical industry

Preferred Requirements:

• Bachelor’s degree in engineering or related field with 9 years ofexperience working in an engineering-based EDMS
• Experience with equipment tagging and standards
• Experience with complex projects and working in operating facilities

Working Conditions & Physical Requirements:

• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time, up to 30 minutes
• Ability to sit for prolonged periods of time, up to 30 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers

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 ([e-mail]).