Process Engineer III
Core
Ensure reliability and compliance of GMP manufacturing equipment, utilities, facilities, and QC laboratory systems to support innovative therapy development and manufacture.
Role type
Senior IC Process Engineer (GMP Manufacturing & QC)
Builds
GMP-compliant manufacturing equipment, utilities, and QC laboratory systems for biopharmaceutical therapy production.
Domain
Biopharmaceutical manufacturing and Quality Control (QC)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP equipment lifecycle management, validation principles, root cause analysis, CAPA implementation, FDA regulation knowledge, cross-functional project leadership, technical writing, instrumentation support, equipment reliability strategies, capital project management, engineering documentation (URS/FS/DDS)
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead GMP equipment lifecycle activities including installation, commissioning, qualification (C&Q), and validation; Investigate equipment deviations and implement CAPAs; Serve as SME during FDA inspections and internal audits; Develop equipment reliability and maintenance strategies; Create and maintain engineering documentation; Partner with cross-functional teams to evaluate new technologies.
Seniority
Senior, hands-on IC
