Senior Project Engineer
Core
Designing, specifying, and commissioning biopharmaceutical process equipment, piping, and controls while supporting manufacturing processes and existing equipment.
Role type
Senior IC project engineer (biopharmaceutical manufacturing)
Builds
cGMP process equipment, piping, controls, and manufacturing infrastructure
Domain
Biopharmaceutical manufacturing and process engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
chemical/process/mechanical engineering, cGMP equipment design, piping and instrumentation diagrams (P&IDs), process flow diagrams (PFDs), lifecycle documentation review, cleaning validation protocols, change control documentation, contractor supervision, safety incident investigation
Preferred skills
biopharmaceutical process equipment experience
Technologies
P&IDs, PFDs, cGMP equipment, control systems
Responsibilities
Design and specify cGMP process equipment, piping, and controls; manage small-to-mid-sized projects related to process equipment; prepare P&IDs and PFDs; assist in design review, site acceptance, and installation; support QA Validation department with design documents and protocol execution; review and approve lifecycle documentation and validation reports; investigate process equipment and control system anomalies; supervise mechanical, electrical, and automation contractors; implement corrective/preventative actions
Seniority
Senior, hands-on IC with supervisory duties