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5.0 - 9.0 years
0 Lacs
chennai, tamil nadu
On-site
The job requires a Techno-Functional Lead with extensive experience in Siemens Opcenter Execution Pharma (Simatic IT eBR) to lead the functional design and implementation of electronic batch records (eBR) and manufacturing processes for global pharmaceutical clients. You will collaborate with Business SMEs/Key Users to gather functional requirements, design and configure Process Instructions (PIs), and ensure GxP compliance. Additionally, you will be responsible for developing comprehensive documentation such as URS, FRS, Design Specs, and Test Scripts. You will identify common manufacturing processes and design reusable global PIs, mentor MES consultants and engineers, and report project status to internal leadership and client stakeholders. The ideal candidate should possess a strong understanding of manufacturing processes in the pharmaceutical industry, proficiency in designing, validating, and implementing Process Instructions (PIs) in Siemens Opcenter Execution Pharma (Simatic IT eBR), hands-on experience in documentation and validation lifecycle, and the ability to effectively communicate with cross-functional teams. Experience in leading project teams and managing deliverables in a structured environment is essential for this role.,
Posted 4 days ago
3.0 - 8.0 years
5 - 10 Lacs
Chennai
Work from Office
We are looking for an experienced MES Engineer with strong knowledge in Siemens Opcenter Execution Pharma to support the implementation and lifecycle management of MES solutions within GMP-compliant pharmaceutical manufacturing environments. This role involves configuring electronic batch records integrating with other systems (ERP SCADA LIMS) and ensuring regulatory compliance. Key Responsibilities: Configure test and deploy MES solutions using Siemens Opcenter Execution Pharma. Design and implement Electronic Batch Records (EBRs) based on process requirements. Work closely with manufacturing QA and automation teams to gather and translate business requirements. Ensure system validation and documentation according to GMP and GAMP 5 guidelines. Support system integration with ERP LIMS and automation layers (ISA-95 model). Troubleshoot MES application issues and provide operational support. Maintain SOPs technical specifications and validation documentation. Contribute to audits inspections and data integrity compliance. Skills & Attributes: Strong experience with Siemens Opcenter Execution Pharma (formerly SIMATIC IT eBR). Deep understanding of pharmaceutical processes and regulatory frameworks (21 CFR Part 11 GAMP). Proficient in creating and validating EBRs recipe modeling and MES workflows. Knowledge of system integration especially with SAP SCADA/DCS and LIMS. Excellent analytical documentation and communication skills. Team-oriented with a proactive approach to problem-solving. Ability to work in cross-functional and regulated environments. Contact Person : - Anusiya Contact Number : - 9840114871 Location : - Pan India
Posted 2 months ago
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