Process Engineer II
Core
Design, optimize, and validate purified water systems, chemical formulation processes, and sanitary fluid handling equipment for clinical diagnostic reagent manufacturing.
Role type
Process Engineer II (regulated manufacturing)
Builds
High purity water generation systems, chemical formulation processes, storage and distribution, filtration, piping, pumps, valves, and mixing systems
Domain
Medical diagnostics / Biotechnology / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical design, P&ID creation, cGMP compliance, fluid handling system design, equipment specification, vendor selection, FAT/SAT, commissioning, IQ/OQ/PQ, root cause analysis, risk assessment (FMEA), technical writing, CAD software proficiency
Preferred skills
Purified water system experience (RO/DI), pump sizing, skid design, Lean Six Sigma, aseptic processing knowledge, process automation
Technologies
AutoCAD, Solidworks, SAP, MasterControl, Blue Mountain
Responsibilities
Lead engineering support for high purity water systems; Design and optimize sanitary fluid handling systems; Support chemical formulation and mixing operations; Develop and revise P&IDs and engineering documentation; Lead equipment specification and commissioning activities; Troubleshoot fluid process equipment and implement improvements; Author and revise SOPs and validation protocols; Lead deviation investigations and CAPAs; Partner with cross-functional teams for cGMP compliance; Support continuous improvement and capital engineering projects
Seniority
Mid-level IC (2-3 years experience)
