MES Lead/ Senior MES Professional

Job Description Inventia Healthcare has been a trusted name in pharmaceutical development and manufacturing for over 40 years. We partner with global pharmaceutical companies to research, develop, manufacture, and distribute oral solid dosage (OSD) forms. Our state-of-the-art manufacturing plant in Ambernath produces a wide range of OSD formulations, including capsules, tablets, granules, and pellets. With a strong international presence across 45 countries and more than 10 regulatory approvals (including USFDA and EU), Inventia has built a reputation for quality, innovation, and reliability. We operate from our corporate office in Goregaon and a cutting-edge R&D center in Thane, driving continuous advancements in drug delivery and formulation. Recently, Platinum Equity acquired a controlling stake in Inventia Healthcare, further strengthening our global capabilities and growth vision. Job Description MES Lead / Senior MES Professional Experience: 15+ years overall, including a minimum of 5 years in MES implementation, operations, and management. Role Overview: We are seeking a highly experienced MES Lead / Senior MES Professional to drive end-to-end MES (Manufacturing Execution System) strategy, implementation, integration, and operations. The role demands a mix of strategic leadership and hands-on technical expertise, ensuring MES serves as a backbone for manufacturing excellence, compliance, and digital transformation. Key Responsibilities: - Develop and execute MES implementation strategy aligned with business goals, including phased rollouts and scalable solutions. - Actively manage MES operations to ensure minimal downtime and smooth functioning. - Perform root cause analysis and personally resolve post-implementation issues. - Collaborate directly with operations, IT, quality, and production teams to configure and optimize MES functionalities. - Conduct hands-on training sessions and provide user support to ensure system proficiency. - Identify opportunities to optimize manufacturing workflows using MES data, and implement improvements directly. - Evaluate and configure new MES features/modules to enhance system functionality. - Collect and analyze user feedback, and translate it into actionable system enhancements. MES & Systems Integration: - Define and implement integration strategies between MES and L2 systems (e.g., PLCs, SCADA, DCS). - Ensure real-time data exchange between shop floor equipment and MES, performing hands-on troubleshooting and configuration. - Work closely with automation engineers to align MES functionalities with equipment capabilities. - Resolve integration issues and optimize system performance through direct involvement. Governance & Compliance: - Manage controlled changes to MES configurations, workflows, and integrations. - Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11). - Monitor and enforce data integrity policies across MES operations. - Drive continuous improvement initiatives, personally implementing key enhancements. - Track and report KPIs related to system uptime, compliance, and project milestones. Enterprise Alignment & Strategic Initiatives: - Integrate MES with enterprise systems (SAP, LIMS, QMS) through hands-on configuration and testing. - Plan MES expansion to new sites, lines, or products, performing setup and validation. - Ensure MES aligns with broader digital transformation initiatives of Inventia IT . - Utilize MES data for operational insights, predictive analytics, and decision-making. - Provide updates to senior leadership with hands-on demonstrations of MES performance and capabilities. - Maintain strong relationships with MES vendors and coordinate upgrades or support tasks directly. - Mentor and guide MES support and enhancement teams, while actively contributing to system work. Location : Ambernath