Job Description

About Leading-Biotechnology-CompanyANSR, a market leader in enabling organizations to build, manage and scale global teams, is partnering with a renowned biotechnology company who is redefining the future of human health by providing solutions to some of the most complex problems in the healthcare industry. They are committed to making precision medicine accessible and carries out their business operations in an environmentally sustainable way.Now is your opportunity to join their innovative team in Bengaluru, India. For over 20 years now, companies cutting across size, industry and markets have relied on ANSRs expertise to successfully build global business and technology teams. We can help you land a rewarding career in this dynamic industry.If you are eager to contribute to a company with strong values, a supportive environment and where you get opportunities to work on challenging projects that uses cutting-edge technology to improve millions of lives, this is your chance to join a truly remarkable team. Apply today!About Illumina:Illumina is a leading developer, manufacturer, and marketer of life science tools and integrated systems dedicated to making genomics useful for all. Illuminas integrated Indian global hub in Bengaluru, Illumina India Biotechnology Private Limited, is focused on technology activities that will help usher in the next wave of innovation in healthcare and medical research. If youre eager to work on challenging projects that uses cutting-edge technology to transform the future of healthcare, this is your chance to join a truly remarkable team.This position requires an individual who must work with minimal supervision to manage the system development life cycle for the Illuminas Laboratory Information Management System (LIMS). This person will join a dynamic, fast paced organization supporting new product development teams, as well as sustaining operations. This person is responsible for compiling relevant information related to product and process definition, analyzing business and compliance requirements, assessing risks for impact, and procuring accurate information for use in global systems. In addition to product configuration, development, and change activities, tasks include support and iteration of LabVantage LIMS, management of Engineering Change Requests and Change Orders (ECRs/ECOs), workflow process development, and identification and participation in product and process improvements initiatives.Responsibilities:

• Own, Support, and iterate system development life cycle for LIMS to develop and optimize manufacturing process flows
• Drive improved utilization of LabVantage for laboratory areas with respect to both configuration and core functionality, and act as voice of the customer for manufacturing
• Oversee development of drivers for Scientific Data Management System (SDMS) for instrument connectivity and seamless data integration
• Understanding of master data and the roles played by PLM, ERP, MES, LIMS, etc. in support of manufacturing and product release
• Review and monitor implementation activities to ensure the change has been completed properly
• Responsible for the accuracy of system data through process evaluation and validation
• Develop and maintain product and process configurations and collaborate on the implementation of solutions in LIMS, PLM and ERP. Candidate must have a solid understanding of LIMS/PLM/ERP and changes to downstream cross functional areas and systems
• Able to work independently and requires minimal guidance to perform required tasks
• Work with peers and/or subordinates to ensure timely completion of projects and tasks
• Take initiative to develop and implement new processes to strengthen data accuracy or enhance efficiency
• Demonstrate effective communication style working with all levels of organizational structure, through multiple departments, and across global sites

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.Requirements:

• Experience with software programming languages, Java, Groovy preferred (5+ Years)
• Hands-on experience with 3rd Party interfaces that are commonly interfaced with LIMS applications like ERP, PLM, MES, SDMS, Instruments, etc.
• Technical background in manufacturing, preferably in a life sciences, diagnostic, and/or medical device environment
• Direct hands-on experience managing configuration change management in LIMS, LabVantage LIMS preferred.
• Proven ability to convert process flows into automated workflow models
• Experience in configuration management, operations, and/or quality within a regulated industry
• Solid understanding of computer system and system validations
• Experience with Software Development Life Cycle of quality systems
• Experience with process and material change and configuration activities within an Enterprise Resource Planning (ERP) system, SAP preferred
• Product Lifecycle Management (PLM) experience
• Working knowledge of ISO 13485 and cGMP requirements desired
• High degree of initiative and ownership, as well as a proven history of delivering results while working with several different departments in a fast-paced environment
• Be able to work in AMR time zones on a consistent basis

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Leading-Biotechnology-Company