MES Validation SME (Rockwell MES)
- Location
- Pan India
- Salary
- Not specified
- Company
- Akash pawar
Job description
Role & Company / Project Overview: We are looking for an experienced MES Validation SME with strong expertise in Computer System Validation (CSV) and Rockwell PharmaSuite / Rockwell MES to join our team and support MES implementation and validation activities in a GxP-regulated manufacturing environment. Key Responsibilities & Daily Duties: • Drive end-to-end Computer System Validation (CSV) activities. • Create, configure, execute, and validate MES recipes. • Provide SME expertise across Recipe Management, Workflow Configuration, Material Management, Production Execution, and Electronic Batch Records (EBR). • Author, review, and execute validation documents, test scripts, and other validation deliverables. • Support requirements gathering, functional/design reviews, testing, UAT, deployment, and hypercare. • Collaborate with business, technical, quality, and global project teams. • Participate in Agile ceremonies, sprint planning, and release activities. • Ensure compliance with GxP and applicable quality and validation standards. Required Qualifications, Skills & Experience: • Mandatory Skills: - Strong hands-on experience in Rockwell PharmaSuite / MES Validation. - Strong experience in CSV within regulated environments. - Hands-on expertise in Rockwell PharmaSuite / Rockwell MES. - Proven experience in MES recipe creation, configuration, testing, and validation. - Strong understanding of SDLC, UAT, and deployment activities. - Experience with test management tools such as ALM, qTest, or similar. - Excellent communication, documentation, and stakeholder management skills. • Good to Have: - Knowledge of MES integrations with ERP, LIMS, and automation systems. - Experience working in Agile delivery environments. Working Hours, Shifts & Location Details: • Location: Remote • Joining Timeline: Immediate Joiner - 15 Days Application Instructions: • Interested candidates please share your updated resume via email.