Manager it

Hi, We are having an opening for Manager IT - MES SME at our Halol or Baska(Gujarat) location. Job Summary : We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems. The Site SME MES Project is a key functional and technical expert responsible for supporting the successful implementation of the Manufacturing Execution System (MES) & L2 at the Halol & Baska pharmaceutical manufacturing sites. This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution. The SME is also accountable for leading site-level validation activities and technical owner responsibility , and managing all Gx P documentation related to the MES & L2 system. The Site SME is the go-to authority for end-to-end MES product knowledge. This includes a deep understanding of system functionality, configuration, and compliance requirements. The SME also serves as the first point of contact for any MES front-end application issues, supporting users in troubleshooting, training, and ongoing system usage post-go-live. The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5) Previous experience with Werum (Korber Pharma) for pharma industry is a big plus Areas Of Responsibility : MES Implementation: Representing site-specific needs during MES design, configuration, and deployment. Validation Leadership: Leading IQ, OQ, PQ, UAT, and traceability matrix execution. Documentation Ownership: Managing Gx P documentation (URS, FS, DS, test cases, validation plans/reports). MES Product Expertise: Maintaining deep knowledge of MES functionality and architecture. Front-End Support: Acting as the first point of contact for MES application issues and user support. Training & Adoption: Delivering training and ensuring user readiness for MES usage. Data Management: Supporting data collection, migration, and master recipe creation. Audit Readiness: Ensuring all documentation and systems are compliant and audit-ready. Educational Qualification : Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. Preferred: Masters degree (e.g., MBA, M. Tech, M. Pharm) with specialization in Industrial Automation, Pharmaceutical Technology or related technical fields Specific Certification : GAMP 5 for system validation in regulated environments. CSV (Computer System Validation) for compliance with Gx P. MES Platform Certifications e.g., Werum PAS-X, Siemens Opcenter, or Rockwell 21 CFR Part 11 Compliance Training for electronic records and signatures Experience : 6 to 8 years of experience Pharmaceutical Manufacturing: Strong understanding of pharma shop floor operations and regulatory requirements. MES or Digital Systems: Prior hands-on experience with MES platforms or similar systems in Gx P-regulated environments. Validation Expertise: Proven experience in validation documentation and execution, especially for Gx P Category 4 & 5 systems. Application Support: Experience in resolving front-end MES issues and supporting end-users post-deployment. Audit Experience: Familiarity with audit processes and documentation expectations Skill (Functional & Behavioural): Functional: MES system configuration, deployment, and validation, Front-end application troubleshooting and user support, Gx P and 21 CFR Part 11 compliance, Validation protocol development and execution (IQ, OQ, PQ, UAT), Documentation management (URS, FS, DS, traceability matrices), Data migration and master recipe creation Behavioral: Strong communication and interpersonal skills, Proactive problem-solving and risk management, High attention to detail and compliance mindset, Ability to work under pressure and manage multiple priorities, Detail- oriented with a focus on compliance and quality, Proactive problem-solving and decision-making, Comfortable working on the shop floor and in technical environments Additional Skills: (Good to have) Knowledge of data analytics tools Edge Cloud deployment experience with (Io T and and IIo T) L2 integration with MES MES integration with SAP Understanding of network and databases