Sr Associate Operations & Engineering Documentation
Core
System coordinator for engineering and operations documentation management systems in pharmaceutical/biotechnology manufacturing.
Role type
Senior Associate Operations & Engineering Documentation
Builds
Compliant documentation for manufacturing and engineering/maintenance operations
Domain
Pharmaceutical/Biotechnology manufacturing
Required skills
CMMS administration, Master Batch Record authoring, electronic logbook management, SOP authoring, change request management, cGMP knowledge, FDA regulations knowledge, data analysis, trend monitoring, AI tool proficiency
Preferred skills
Experience with digital systems in pharma, experience with generative AI tools
Technologies
CMMS, SDS, PGS
Responsibilities
Develops data elements in CMMS for equipment and maintenance plans; Administers CMMS system; Authors and approves Master Production Batch Records; Authors and approves electronic logbooks; Authors and approves standard operating procedures; Manages Change Requests and Periodic Reviews; Coordinates commitment and quality drivers for documentation updates; Reviews and files executed maintenance and production documents; Supports regulatory and internal audits.
Seniority
Senior, hands-on IC
