Sr Engineer
Core
Independently provides and directs characterization of process optimization strategies and troubleshooting of operational issues in manufacturing, pilot plant, or capital projects environments.
Role type
Senior Manufacturing Process Engineer
Builds
Manufacturing processes, capital projects, and operational improvements for pharmaceutical/biotech clients
Domain
Pharmaceutical/Biotech Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process optimization, Root Cause Analysis, CAPA management, Risk Assessment, Microbial assessment, MBR creation, Standard Operating Procedure development, Equipment modification assessment, BOM change assessment, Technical protocol generation
Preferred skills
CMMS system ownership, Equipment reliability strategy, Equipment performance metrics development, Equipment improvement project leadership, Compliance operations expertise, Equipment troubleshooting, Environmental Health and Safety compliance
Technologies
CMMS, Specialized laboratory equipment, Computers
Responsibilities
Own change controls for manufacturing process changes; Support major/trend deviation investigations including Root Cause Analysis and Corrective/Preventive Actions; Lead commercial campaign readiness and cross-functional collaboration; Design, coordinate, and support execution of functional tests and water tests; Initiate, revise, and approve standard manufacturing procedures; Assess process performance and implement solutions for process improvement opportunities; Serves as a peer-recognized specialist in at least one area determining methodologies.
Seniority
Senior, hands-on IC
