MES LCM / CSV Engineer
Core
Managing the lifecycle, optimization, and validation of MES systems (WERUM PAS-X) and leading Computer System Validation (CSV) projects in regulated environments.
Role type
MES LCM / CSV Engineer
Builds
Validated MES systems and compliant computerized systems for Pharma/Biotech clients
Domain
Pharma/Biotech, GxP, Automation
Required skills
MES lifecycle management, CSV project leadership, GxP compliance assessment, risk analysis, data integrity, URS/FS/HDS documentation, DQ/IQ/OQ/PQ qualification planning, FAT/SAT/FT test documentation, system change coordination, stakeholder communication
Preferred skills
WERUM PAS-X experience, SQL or programming language knowledge, MS SQL
Technologies
WERUM PAS-X, MS SQL
Responsibilities
Life Cycle Management of MES systems, Support in modeling and optimization of system changes, Integration of new production plants, First Level Support for MES, Execution of Qualifications and Validations, Project leadership for CSV projects, Creation of Qualification Strategies and Compliance Assessments, Creation of Design Documents and Qualification Plans, Execution of Qualification activities at customer sites
Seniority
Mid-level, hands-on IC
