Laboratory Engineer 3
Core
Manage, verify, or perform chemical and microbiological analyses on materials and products, validate analytical methods, and qualify laboratory equipment.
Role type
Senior Laboratory Engineer (Chemical/Microbiological)
Builds
Dialysis products (cyclers, cartridges, dialysate) and medical devices
Domain
Medical device manufacturing / Dialysis / Pharmaceutical quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Chemical and microbiological analysis, analytical method validation, equipment qualification, controlled environment management, inventory control, stability program execution, calibration and maintenance management, regulatory compliance (USP, EP, ISO), pharmacopeia knowledge, IQ/OQ/PQ validation, OOS investigation, CAPA management, Lean Six Sigma
Preferred skills
Advanced English, strategic KPI development, regulatory audit support
Technologies
Spectrophotometers, HPLC, endotoxin readers, TOC analyzers, chromatography, titration
Responsibilities
Manage procurement of lab equipment, materials, reagents, and supplies; Approve physicochemical and microbiological analyses of raw materials, dialysate concentrate, and water; Operate specialized lab equipment including HPLC and endotoxin readers; Manage and control controlled environment areas; Verify culture media and solutions; Monitor temperatures, differential pressures, and control charts; Control and track inventory of chemical, biological, and culture media reagents; Execute method and equipment validation programs; Execute stability programs; Ensure compliance with equipment calibration and maintenance schedules; Ensure adherence to lab safety and hygiene measures; Manage disposal of chemical and biological waste; Develop area procedures (SOPs, forms); Support quality activities to maintain an active quality system; Manage resources for projects with support/engineering areas; Track lab quality metrics (OOS, BPL, Datacard, NCMR, RI, CAPA, SCAR, TD, MRB).
