GMP Engineering Documentation Lead

FUJIFILM; Holly Springs (NC); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Document management

EDMS

SOP enforcement

Transmittals

BIM support

EDMS training

Educación

High School Diploma

Associate's degree

Bachelor's degree

Herramientas

EDMS

Descripción del empleo

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.