MBR Designer(Werum PAS-X)

Job Description

Be at the centre of the digital revolution in Life Sciences!Industry 4.0 is here bringing with it the use of automation, and smart connected technologies to revolutionise manufacturing in the Life Science sector. Due to the increasing complexity of production and manufacturing within the Life Science industry driven by the amazing advances in research, Cognizant and Zenith Technologies are at the forefront of this revolution managing, optimising and controlling drug and medical device production for maximum operational efficiency and regulatory compliance. Ultimately enabling Life Science companies to more efficiently deliver life changing medicines and medical devices to those who need them most. With operating hubs in Ireland, Germany, India, Singapore and the United States, Cognizant and Zenith Technologies work with all of the world’s top 30 Life Science companies to improve the lives of millions of people. Position Overview:We have excitig opportunities for our client based in Amsterdam for experienced Werum PAS-X MES MBR Designers. The role is responsible for configuring Micro Bioreactor receipes and workflows in Werum Pas-X.Key Responsibilities:

• Creating business process flow diagram for pharmaceutical product recipes based on the paper batch record
• Gathering MES Site specific requirement analysis to develop URS and FRS
• Logically breaking down the recipes/Mfg. process following S88 standards ( Procedure, Unit procedures, Operations phases) to configure the recipe in to Werum PAS-X
• Developing/creatingMBR design elements ( building blocks) and workflows in Werum PAS-X for repetitive use in MBR creation to expedite the process
• Gathering master data and configure/ upload in Werum PAS-X D/Q/P Environment.
• Integrating Werum PAS- X with SAP and other automation systems using standard interface. Configuration of system data – work centers, scales, barcode scanners, Printers
• Leading the recipe design session with business process SMEs
• Designing MBR/recipe, equipment workflow/ status diagram based on the Business process flow
• Creating solution design and configuration document
• Assisting Validation engineer in authoring and execution of OQ/SITs including Interface testing
• Supporting Unit testing in D environment and business verification testing in Q environment
• Preparing key user training documents and impart key user training
• Providing assistance in business SOP creation
• Supporting FAT/UAT execution
• Performing go-live/ cut-over activities
• Providing hypercare/early life adoption support

Skills and Competencies

• Werum PAS-X v3.1.8 product hands-on experience for Full application configurations including interface with SAP and automation systems
• In-depth of knowledge of Pharmaceutical business process ( Chemicals ( W&D, Solid bulk Mfg., packaging and other unit operations), Bio Pharma processes)
• Creation of business process flow diagram
• Master Batch Record creation and SKY batch record creation in Werum PAS-X
• Knowledge on Industry Standards S88 as ISA S95

We offer:We offer an innovative and exciting working environment, on-demand learning and skill development through our in-house Cognizant academy; we are a world leading in CSR activity and offer competitive employment benefits.