Engineering Documentation Specialist

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an Engineering Documentation Specialist responsible for paperless document management, data integrity, and project turnover packages.

You will administer the EDMS, enforce SOPs, and collaborate with BIM and IT teams to support GMP engineering activities in a fast-paced biopharma environment.

Qualifications

• High School Diploma or GED with 9 years of document management experience (5 in biopharma).
• Associate's degree in engineering with 7 years of document management experience (5 in biopharma).
• Bachelor's degree in engineering with 5 years of doc mgmt experience in biopharma.

Responsibilities

• Organizes, compiles, and maintains engineering and facility documentation.
• Maintains documentation for existing equipment and manages approval workflows for data integrity.
• Processes project-related documentation and turnover packages for traceability.
• Maintains SOPs and enforces document control procedures across project teams.
• Manages transmittals and external stakeholder communications.
• Collaborates with external Document Controllers for compliance.
• Identifies opportunities to enhance document control processes.
• Integrates project management and quality principles in document control.
• Assists BIM team with documentation standards and execution plans.
• Partners with IT to configure and sustain EDMS.
• Delivers training and provides guidance on EDMS.
• Performs other duties as assigned.

Skills

Document management

EDMS

GMP knowledge

SOPs

Training delivery

Education

Bachelor's degree in engineering

Associate's degree in engineering

High school diploma or GED

Tools

EDMS

Document control software

Job description

Position Overview

The Engineering Documentation Specialist demonstrates complete and thorough understanding of Engineering turnover documentation and is responsible for 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 system and 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 management experience (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 of experience 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

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 place. 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 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 ([e-mail]).