Senior Technical MES Lead

Over 10+ years of experience in MES/Automation execution within the pharmaceutical manufacturing industry including: Expertise in GMP requirements and compliance for complex MES solutions. In-depth knowledge of pharma manufacturing processes including filling, compounding, formulation, OSD, fractionation, purification, etc. Ability to translate manufacturing processes into MES solutions across various ISA-95 layers, ensuring proper data modeling and defining sources of truth. Proven experience with MES/Control systems integration (e.g., DeltaV, FactoryTalk, DCS, etc.). In-depth understanding of SAP order management, inventory, and materials management modules, with a focus on MES integration. Extensive experience in the design and implementation of MES software (e.g., Syncade, PharmaSuite, PMX, PAS-X). Proficient in reviewing and troubleshooting recipes, making necessary updates to meet client specifications. Familiarity with validation tools such as Kneat and HP ALM. Proven experience in developing MES validation strategies, test scripts, and execution plans. Track record of delivering MES training across all levels of the organization (e.g., operators, supervisors, quality teams). Ability to prioritize and work under aggressive schedules.