Functional Lead

2 weeks ago

Srikakulam, India Live Connections Full time

Opcenter Execution Pharma – Techno-Functional Job Title Opcenter Execution Pharma – Techno-Functional Designation: Associate, Senior Associate and Manager Experience: 4 to 12 years Salary: 10+Lacs to 25+Lacs Location: PAN India Job Summary Be part of a high-impact global digital transformation program in the pharmaceutical sector. As the Techno-Functional Lead for Opcenter Execution Pharma, you will play a pivotal role in designing, configuring, and rolling out next-generation electronic Batch Recording (eBR/MBR) solutions across multiple manufacturing sites worldwide. This is a true leadership position combining deep functional expertise with hands-on configuration and team leadership. You will bridge the gap between pharmaceutical manufacturing operations and cutting-edge MES technology, delivering compliant, efficient, and harmonized global Master Batch Records that directly contribute to patient safety and operational excellence. Key Responsibilities Time Responsibility. Engage with business SMEs, key users, and site leadership to deeply understand current and future manufacturing processes (upstream, downstream, fill-finish, oral solid dosage, etc.) Lead the design and configuration of Production Instructions (PIs), workflows, and Master Batch Records (MBRs) tailored to site-specific needs Identify common processes across sites and design reusable Global PIs / Global MBR templates for maximum harmonization and faster rollouts Drive validation activities including review and approval of PIs, risk assessments, and traceability matrices Author and review GAMP 5-compliant documentation (URS, FRS, Configuration Specifications, Test Scripts, Deviation Reports, etc.) Lead and mentor a team of MES functional consultants and configurators; assign tasks, track progress, and ensure quality delivery Ongoing Report status, risks, and achievements to leadership and customer program management Essential Skills & Experience Extensive hands-on experience in Opcenter Execution Pharma / Simatic IT eBR (design, configuration, and validation of MBRs/PIs) Strong functional knowledge of pharmaceutical manufacturing processes (GMP environment) Strong experience in creating and reviewing GxP documentation (URS, FRS, DS, IQ/OQ/PQ protocols, traceability matrices) Prior experience leading or mentoring a team of functional/configurators Solid understanding of ISA-88, ISA-95, and GAMP 5 principles Nice-to-Have Skills Experience with Opcenter Execution Core (Discrete/Process) or other MES platforms (PAS-X, Rockwell PharmaSuite, POMSnet) Knowledge of Review-by-Exception (RbE), dynamic scheduling, or integration with ERP (SAP) and LIMS Certification in Opcenter/MES solutions Experience in large-scale global rollout programs Location & Work Model Hybrid / Remote with occasional travel to client sites (Europe, US, or Asia based on project phase) Please Mail me your updated profile to victorpaul@livecjobs.com With Regards, Victor

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