MES Lead/ Senior MES Professional

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 ProfessionalExperience: 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