Needs for MES

Job Description

Job Title: MES (Manufacturing Execution System) Job Location: BangaloreAbout Syngene : Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spiritMandatory expectation for all roles as per Syngene safety guidelinesOverall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all timesRole Accountabilities Receiving processes from other Syngene BU s and Clients by co-ordinating with Project Management, Process R&D and Business Development Preparation of RFPs for the projects shared by Business development Preparation of EBMR in co-ordination with Production & Process R&D Support Production team for scale up and execution of initial batches & Validation Working for process improvement in running products Be part of improvement in utilities and energy management Support CFT for preparation of scale up and Validation report. Mapping of the process in MSEZ facility Preparing list of modification / facility required in Production facility to execute the process Co-ordinate with the CFT to plan, execute and complete the proposed modifications / additional facility Investigate and resolve production team issues troubleshooting Advise and train production team of EBMR application Configure and deploy MES as required by production team Organize and teach best practice of EBMR design and execution trainings for the production teamSyngene ValuesAll employees will consistently demonstrate alignment with our core valuesExcellence Integrity ProfessionalismSpecific requirements for this role1. Experience: Minimum 5 years of experience as Technical SME MES(eBMR) end Implementation and minimum five experience in Industrial Automation and Instrument Engineering2. Education: BTechSkills and Capabilities Expertise in managing MES (eBMR) application projects, creating and managing the estimates, project plan, project governance, budget, resource allocation, risk, and quality management Must have experience in Paperless manufacturing, cGMP, FDA 21 CFR Part 11 compliance & ISA 88/95 requirements. Preferable, have experience with MES solutions from pharma domain compatible MES solutions for end to end implementation in a highly automated Life Sciences manufacturing environment. Must have experience in MES Transformational projects and conceptual understanding of Industry 4.0/ Pharma 4.0 Must have experience in IT-OT integration projects, the experience of handling DCS, SCADA, PLC, Industrial Communication protocol (OPC, Ethernet, TCP/IP, Modbus, and Profibus, etc.) other Operational Technology L2 Integration. Should have knowledge & experience Integration of Weighing Scales and Label printers of Weighing Scales. Expertise in ensuring the delivery of high-quality services to support organization business needs & achieve high customer satisfaction from business users Must have experience of handling a team of 3-4 no s and Change Management process part of MES implementation Should have experience exposure to EBR Recipe Management (Edit/Author/Develop/Configure) for Electronic Batch Records (EBR). Knowledge of FDA and GMP guidelines for paperless manufacturing and understanding of pharma validation processes. Must have knowledge of QMS process and QMS procedures, i.e., Deviation, Investigation, CAPA. Change Control procedures. Ability to work within a team with colleagues from a wide range of professional backgrounds and contribute to the development of team culture and the achievement of common objectives Mus have experience handling Internal Audit and external regulatory Audits FDA Audit coordinates with team support MES-related information and compliance towards 21 CFR part 11.,

Keyskills :
batch recordscontinuous improvement facilitationinternal audit21 cfrchange managementchange control