Werum's PAS-X MES/IT Solutions, Emerson's SYNCADE MES, DeltaV Automation Consultant.

Ensure that automation systems, associated infrastructure and process /utilities equipment are commissioned, qualified and validated in accordance with MSD quality standards and regulatory requirements. Work with Users & Vendors on the Automation system solutions by providing inputs from a Automation and CSV perspective. Support development of overall project schedule and provide input through full lifecycle, providing regular updates and progress reports. Provide SME guidance to end users and vendor across all project phases. Lead effort to develop/review/approve all project execution / SDLC document deliverables.

Worked at Novartis BioPharma Ops Singapore for 4.5 yrs as an DeltaV Automation Consultant to provide support to the Automation System within Novartis. This includes: Providing Automation support in Designing, Commissioning, Qualification and Start-up of the new BiopharmOps Singapore (production and utilities system). Work with Automation User Team to support day-to-day activity of the PU (Process Units), MS&T (Manufacturing Science & Technology) and SE (Site Engineering); provide engineering support for the Change Controls of the automation systems. Ensure that supporting GxP related documentations are generated and maintained current.

Techno Functional Team Lead/ EBR Solution Architect/ Recipe Authoring(RA) Architect for various DeltaV as well as Syncade Projects:• Deputed to USA, Denmark for multiple projects designing and commissioning activities. Syncade (MES) and DeltaV solution designing which includes preparation of Functional specification for Recipes of various process stages/areas (Bioreactor, Ultrafiltration, Chromatography, Buffer Prep, Media Prep, Inoculation, Granulation, Drying and Crystallization), ET work orders, DCA Change request workflows. Participate in Requirement Gathering & Analysis process. Prepare AS-IS and TO-BE process mapping workflows. • Preparation of Functional Specification for various Syncade Modules (Security and Audit, Admin, Weigh and Dispense, Equipment Tracking, Material Master, Inventory Management, Order Management, and Document Control module). • Designing, Configuration, FAT, IQ OQ Specification preparation and execution of Syncade Master Recipes for various process areas and steps, ET Workflows, DCA CR workflows, Equipment Tracking state matrix; rules & events for the Equipment classes, Designing and configuration of Security and Audit, Weigh and Dispense, Admin, Material Master, Inventory Management, Order Management, and Document control modules of Syncade MES suite.• Designing, Configuration, FAT, IQ OQ Specification preparation and execution of DeltaV Unit Procedures, Operations, Phases, Equipment Modules and Control Modules.• Leading FAT, SAT, Commissioning, Validation and site support activities for Syncade and DeltaV projects.

Projects worked on: Project Title: Genentech Syncade MES Oceanside, CA U.S.• Client : Emerson Philadelphia, End User: Roche GenentechActivities: Deputed to Genentech Oceanside CA for Commissioning and after Commissioning support. Syncade Recipes, ET Workflows designing and configuration. FAT at Emerson Austin.  Project Title: Lonza 101B EBR Syncade MES, Portsmouth U.S.• Client : Emerson Philadelphia, End User: Lonza Bio Tech Activities: Deputed to Lonza Porthsmouth for design and development activities. Syncade Recipe design lead for Buffer and Media, Chromatography areas. FOK recipes demonstration to Lonza QA for concept approval. Integrated recipe testing in FAT. Execution of IQ, OQ for Buffer and Chromatography recipes. Project Title: BMS LSCC Syncade MES and DeltaV implementation, Devens, U.S.• Client : Emerson Austin, End User: BMS LSCC Activities: Deputed to BMS Devens for commissioning activities. Configuration and testing of Equipment Modules, Phase Class, Unit Class, Unit Failure Modules and Unit Support Modules in DeltaV. Develop recipe components in Syncade for Buffer prep, and Buffer hold, Media prep, Centrifuge, Purification area as per FS.

 Detailed project engineering & software development:• Discus process and control philosophy with client.• Application coding and configuration in 800xA Batch Control System. • Application documentation, FAT documentation of project.• Internal testing, Factory Acceptance Testing of project with customer.• SAT & Commissioning of project at project location.Projects worked on being in UK, Ireland: Project Title: GlaxoSmithKline - Fosamprinavir, UK. • Client : ABB UK End User: GSK - Dart ford UK Project Title: GlaxoSmithKline - Valaciciovir, UK. • Client : ABB UK End User: GSK - Dart ford UK Project Title: Janssen Pharmaceutical Ltd - P2 PCS Replacement, Ireland. • Client : ABB Ireland End User: Johnson & Johnson- Cork IrelandActivities: Preparation of Software Module Design Specification with respect to the customer Functional Specification for Phases, Equipment Modules, Shared Equipment Modules, Units, Control Modules, Operations and FAT Documents. Application Coding includes Coding for Phases, Equipment Modules, Shared Equipment Modules, Units, Control Modules and Operations. FAT, SAT and Internal Testing of Units, Phases, EMs, CMs, Operations. Involved in site commissioning activities, execution of IQ, OQ.

Detailed project engineering & software development:• PLC hardware detailed design, control philosophy, panel design, wiring diagram preparation.• Control logic development.• HMI & SCADA application development.• Control panel & wiring diagram design, inspection & testing.• Final installation & control system commissioning at plant location