Expert Standards LMSAT
Core
Technical expert ensuring mastery and effective implementation of LMSAT standards for pharmaceutical manufacturing processes and product lifecycle.
Role type
Senior technical expert (standards & validation)
Builds
Production of high-quality pharmaceutical products and vaccines
Domain
Biopharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing standards implementation)
Required skills
Product lifecycle management (PLM), Cleaning validation, Contamination control (microbial, particulate, E&L), Visual inspection, Single-use systems (SUS), Risk management, Project management, Regulatory knowledge, Technical writing
Preferred skills
Cross-functional team experience, Matrix environment navigation, Continuous improvement initiatives, Stakeholder influence
Technologies
PLM systems, GxP compliance tools
Responsibilities
Act as technical reference for LMSAT standards, Coach and support site teams, Define and evolve technical standards, Develop performance indicators (KPIs), Collaborate with global experts, Maintain knowledge of regulatory requirements
Seniority
Senior, hands-on IC
