REQUIREMENTS

Total experience: 4+ years
Strong experience in Siemens OpCenter Pharma (MES) with end-to-end implementations
Mandatory experience in Recipe Authoring / MBR (Manufacturing Batch Record) design
Good understanding of ISA S88 standards and batch process modeling
Experience in designing operations, unit procedures, and recipes aligned with MBR
Strong knowledge of pharmaceutical/biotech manufacturing processes
Hands-on experience with Electronic Batch Records (EBR) design and validation
Experience with GxP systems, CSV (Computer System Validation), and SDLC methodologies
Good understanding of 21 CFR Part 11 compliance and regulatory requirements
Exposure to quality and manufacturing impacts in MES implementations
Knowledge of MOM platform and integration capabilities
Experience in process development and manufacturing execution in pharma/biotech domain
Strong stakeholder management and ability to work with cross-functional teams
Experience in leading teams or handling complex project deliveries

RESPONSIBILITIES

Lead Siemens OpCenter MES solution design and implementation
Analyze business process flows and translate them into MES recipes and workflows
Design and develop recipes, operations, and unit procedures aligned with S88 and MBR
Collaborate with business and manufacturing teams to ensure process alignment and compliance
Drive EBR design, configuration, and validation activities
Ensure compliance with GxP, 21 CFR Part 11, and validation standards (CSV)
Conduct requirement workshops and convert them into functional and technical MES designs
Support UAT, system validation, and production deployment activities
Identify and manage quality and manufacturing risks during MES implementation
Work on integration of MES with upstream/downstream systems
Provide technical leadership, mentoring, and governance for MES projects
Drive continuous improvements and innovation within MES/MOM landscape

Associate Staff Engineer,Siemens OpCenter