28 Oct
|
Sun Pharmaceutical Industries
|
Halol
28 Oct
Sun Pharmaceutical Industries
Halol
Title :Manager 2, MES - SME**:
- Date: Jul 6, 2026
- Location: Halol 1 - Information Technology
- Company: Sun Pharmaceutical Industries Ltd Job Summary
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” 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 GxP 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.
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 GxP documentation (URS, FS, DS, test cases, validation plans/reports). MES Product Expertise : Maintaining deep knowledge of MES functionality and architecture.- 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. Travel Estimate Less Job Scope
Internal Interactions (within the organization)
Global MES Program Team : Collaborating to align site processes with global standards and system templates. Quality Assurance (QA) & QA IT : Ensuring validation and compliance with GxP and CSV standards. Business Users : Engaging with production, quality, and operations teams for requirements gathering and support. Engineering & IT Teams : Coordinating technical aspects of MES deployment and integration. Site Leadership : Providing updates on MES implementation, validation status, and issue resolution. End Users : Supporting MES usage, troubleshooting front-end issues, and providing training. External Interactions (outside the organization)
MES Vendors & Consultants : Participating in workshops, configuration sessions, and demos; resolving technical issues.
Auditors & Regulatory Bodies :Supporting audits by ensuring system and documentation compliance. Third-Party Validation Experts :Collaborating on validation strategy and execution if outsourced.- Geographical Scope Primary Sites: Halol and Baska manufacturing sites Financial Accountability (cost/revenue with exclusive authority) No direct financial authority Job Requirements
Educational Qualification Bachelor’s degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. Preferred : Master’s 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 GxP.MES Platform Certifications - e.g., Werum PAS-X, Siemens Opcenter, or Rockwell21 CFR Part 11 Compliance Training - for electronic records and signatures. Experience
Pharmaceutical Manufacturing : Solid understanding of pharma shop floor operations and regulatory requirements. MES or Digital Systems : Prior hands-on experience with MES platforms or similar systems in GxP-regulated environments. Validation Expertise : Proven experience in validation documentation and execution, especially for GxP 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) : Behavioral : Strong communication and interpersonal skills, Proactive problem-solving and risk ma
📌 Manager 2, Mes - Sme (Halol)
🏢 Sun Pharmaceutical Industries
📍 Halol