Process Engineer I
Core
Provide engineering, validation, and maintenance support for process manufacturing equipment, facility, and utilities in a pharmaceutical/biopharmaceutical setting.
Role type
Process Engineer I or II (IC)
Builds
Maintains validated state of manufacturing equipment including support systems (portable assets, bench-top instruments, bio-safety cabinets, incubators, freezers) and provides backup for major processing equipment (bioreactors, tangential flow filtration, chromatography, filling equipment).
Domain
Pharmaceutical/Biopharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment lifecycle management, preventative maintenance execution, vendor coordination for calibration/qualification, deviation investigation and corrective action development, FDA/GMP audit participation, equipment performance monitoring, new technology evaluation
Preferred skills
Strong technical writing, problem analysis within defined procedures, building internal/external working relationships
Technologies
Bioreactors, tangential flow filtration, chromatography, filling equipment, bio-safety cabinets, incubators, freezers
Responsibilities
Ensure new equipment is designed/qualified and existing equipment is maintained in compliance; execute administrative preventative maintenance; facilitate maintenance/calibration/qualification with external vendors; own and manage small to medium changes to maintain validated state; investigate equipment/process deviations and develop corrective actions; participate in FDA and internal audits as SME; monitor equipment performance against reliability strategies; evaluate new technologies and equipment platforms
Seniority
Junior to Mid-level, hands-on IC
