Senior Project Engineer
Core
Designing, specifying, and commissioning biopharmaceutical process and clean utility equipment while leading deviation investigations for manufacturing processes.
Role type
Senior IC project engineer (biopharma)
Builds
cGMP process equipment, piping, controls, and clean utility systems for life-changing medications
Domain
Biopharmaceutical manufacturing and process engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP process equipment design, piping and instrumentation diagrams, process flow diagrams, engineering documentation, project planning and scheduling, process control systems, automation knowledge, biopharmaceutical equipment expertise, corrective/preventative action implementation, contractor supervision
Preferred skills
biopharmaceutical process equipment experience, cross-cultural communication, leading without direct authority, resiliency
Technologies
P&ID software, PFD tools, engineering documentation systems, control system interfaces
Responsibilities
Design and specify cGMP process equipment, piping, and controls; manage mid-to-large sized projects including start-up and commissioning; lead design reviews and site acceptance; prepare P&IDs and PFDs; support QA/Validation with design documents and protocol execution; investigate equipment anomalies and safety incidents; implement corrective actions; prepare engineering evaluations for change control; supervise mechanical, electrical, and automation contractors
Seniority
Senior, hands-on IC
