Specialist - Manufacturing - Engineering Support
Core
Support manufacturing team by drafting, revising, and managing technical documentation (SOPs, WIs, protocols) and quality records (deviations, CAPAs, change controls) in a GMP regulated environment.
Role type
Manufacturing Engineering Support Specialist
Builds
Manufacturing documentation and quality system records
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Technical writing, GMP compliance, Quality Management System (QMS) knowledge, deviation/CAPA/change control management, process improvement, troubleshooting, data collation
Preferred skills
Science or Engineering degree, GMP pharma/biotech experience, device assembly/packaging knowledge, visual communication (drawings/diagrams), problem-solving
Technologies
GMP systems, QMS tools
Responsibilities
Develop and update SOPs, WIs, and technical reports; Generate and own quality records (deviations, CAPAs, change controls); Provide clerical support for document preparation and tracking; Liaise with cross-functional departments on documentation changes; Collaborate on training documentation; Support continuous process improvement and troubleshooting; Ensure documentation actions are completed on time and schedules are maintained.
Seniority
Individual Contributor