Associate Staff Engineer,Siemens OpCenter

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

Qualifications :

Bachelors or masters degree in computer science Information Technology or a related fields

Remote Work :

Yes

Employment Type :

Full-time