Padmi

Senior MES Analyst

BangalorePosted 1 month ago
Computer Systems AnalysisSenior
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Senior MES Analyst Job Summary The Senior MES Analyst will play an important role in the design, configuration, testing, documentation, and implementation of Manufacturing Execution System solutions for pharmaceutical and biotech manufacturing environments. The role supports the delivery of compliant, efficient, and reliable digital manufacturing solutions aligned with customer requirements and regulatory expectations. Location: Bangalore, India Experience: 6-8 years Department: Manufacturing Operations Management Responsibilities Support the design, configuration, testing, and implementation of MES solutions for pharmaceutical manufacturing projects. Translate manufacturing and business requirements into MES functional specifications, workflows, and configuration elements. Work with MES platforms such as PAS-X or equivalent systems to support electronic batch management and digital manufacturing execution. Prepare and review MES project documentation, including functional specifications, configuration documents, test scripts, and validation deliverables. Execute and support unit testing, integration testing, user acceptance testing, and validation activities in line with project requirements. Collaborate with Process, QA, Automation, IT, and Operations stakeholders to ensure MES solutions are aligned with GMP and business needs. Support issue analysis, troubleshooting, defect resolution, and continuous improvement of MES configurations and processes. Ensure MES deliverables are developed in accordance with GMP, GAMP5, Data Integrity, Annex 11, and 21 CFR Part 11 expectations. Participate in customer workshops, requirement clarification sessions, design reviews, and project coordination meetings. Support knowledge sharing and mentor junior analysts or engineers in MES configuration, testing, and documentation practices. Contribute to standardization, lessons learned, reusable templates, and best practices within the MES delivery team. Qualifications In all positions there are some things that are needed, and others a bonus. We believe these qualifications are needed for you to do well in this role: Bachelor s or Master s degree in Engineering, Computer Science, Life Sciences, Information Technology, or a related discipline. Minimum 6-8 years of experience in Manufacturing Execution Systems, preferably within pharmaceutical, biotech, or regulated manufacturing environments. Hands-on experience with MES platforms such as K rber PAS-X or equivalent MES solutions. Good understanding of pharmaceutical manufacturing processes, electronic batch records, recipes, workflows, and production execution concepts. Experience in MES design, configuration, testing, documentation, deployment, and validation support activities. Working knowledge of GMP, GAMP5, Data Integrity, Annex 11, 21 CFR Part 11, and computerized system validation principles. Ability to understand manufacturing requirements and translate them into structured MES solutions. Experience working with cross-functional teams such as Process, QA, Automation, IT, Production, and Validation. Basic understanding of MES integration with automation systems, ERP systems, historians, and other manufacturing applications. Strong analytical, troubleshooting, communication, and stakeholder coordination skills. Ability to work independently on assigned work packages while contributing effectively to the wider project team. Experience supporting documentation reviews, test execution, deviation handling, and issue resolution during MES project delivery.

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