Quality Engineer II in Facilities & Metrology
Core
Ensure manufacturing operations meet highest standards by managing quality systems, regulatory compliance, and facility commissioning within a biotech/pharma environment.
Role type
Quality Engineer II (Facilities & Metrology)
Builds
Robust quality systems supporting manufacturing excellence and regulatory adherence
Domain
Biotechnology / Pharmaceutical Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, CAPA management, GMP compliance, cGMP knowledge, cleanroom operations, audit support, change control management, SOP management, FAT/SAT execution, URS development, deviation investigation, regulatory inspection support, analytical problem solving
Preferred skills
Experience with TrackWise, Veeva, or Kneat, knowledge of ISO standards, process safety management, cleanroom design standards
Technologies
TrackWise, Veeva, Kneat, Microsoft Office
Responsibilities
Lead investigations for equipment breakdowns or process failures and implement CAPAs; Oversee development and execution of URS, FAT/SAT, and facility commissioning; Manage regulated documentation including SOPs, change controls, and deviations; Provide technical expertise and documentation to support audit outcomes; Collaborate with cross-functional teams to maintain robust quality systems
Seniority
Mid-level, hands-on IC