Syngene International—Application Developer - MES/Labelling Systems

Job description

Description: Job Title: Labeling Developer Location: Bangalore (Hybrid) About Syngene: Syngene (www.syngeneintl.com) 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 spirit Mandatory expectation for all roles as per Syngene safety guidelines - Overall 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 times - Hold self and their teams accountable for the achievement of safety goals - Govern and Review safety metrics from time to time Position Summary: The Labeling Developer will be responsible for the development, configuration, and maintenance of labeling systems and reporting solutions supporting the Rewiring CT Labeling and RFI project at client. This individual will have hands-on experience with BarTender label template design, InfoBatch report building, XSLT/XML stylesheet development, and SQL-based data solutions within a GMP-regulated pharmaceutical manufacturing environment. The role requires close collaboration with Quality, Manufacturing, and Document Control teams to ensure that labels and RFI forms meet regulatory and operational requirements, while maintaining validated system status through established IT Change Management processes. Duties/Responsibilities - Design, develop, and maintain label templates in the BarTender labeling system to support clinical and commercial manufacturing operations, including variable data mapping, template versioning, and print trigger configuration. - Build and maintain InfoBatch reports to support manufacturing data visibility, lot genealogy tracking, and Quality oversight. - Develop and maintain core stylesheets using XSLT, XML, and HTML for rendering label and RFI form outputs across printing and electronic display platforms. - Author and optimize SQL queries, stored procedures, views, functions, triggers, and CTEs (T-SQL/SQL Server) to support labeling data flows, report data sources, and system integrations. - Collaborate with Quality, Manufacturing, and Document Control teams to capture and document detailed labeling and RFI form requirements. - Support MES recipe authoring activities and ensure proper integration of labeling outputs within Syncade MES workflows. - Maintain validated system status by executing IT Change Management processes — creating and managing change records in ServiceNow, obtaining pre- and post-change approvals, implementing and deploying changes, attaching required evidence, and closing records in compliance with GMP requirements. - Author, review, and execute system lifecycle documentation including User Requirement Specifications (URS), Design Specifications (DS), Functional Specifications (FS), and test cases in support of GMP validation activities (IQ/OQ/PQ/UAT). - Participate in GMP validation activities, including the development and execution of test protocols in ValGenesis and ALM. - Provide primary application support and troubleshoot issues related to labeling systems, InfoBatch reports, and associated MES integrations in a production manufacturing environment. - Collaborate with cross-functional stakeholders to ensure labeling and RFI solutions align with Quality Management System (QMS) requirements and applicable regulatory standards (FDA, EMA). - Participate in agile ceremonies and update assigned work tickets to reflect real-time progress. - Support on-call rotation for critical manufacturing system issues as required. Required Skills & Experience: - Proficiency in BarTender label design — creating and maintaining complex label templates including variable data, counter fields, database connections, and print triggers for GMP-regulated pharmaceutical manufacturing. - Demonstrated experience building and maintaining InfoBatch reports for manufacturing data visualization, batch record review, and Quality oversight. - Strong XSLT and XML stylesheet development skills for rendering labels, RFI forms, and structured document outputs. - Proficiency in SQL (T-SQL / SQL Server) — including stored procedures, views, functions, triggers, CTEs, error handling, and ad hoc query authoring. - Working knowledge of HTML and related web technologies as applied to label or form rendering. - Experience with IT Change Management processes in a regulated pharmaceutical/biotech environment (e.g., ServiceNow change records, change control documentation, pre/post approval workflows). - Experience operating within a Quality Management System (QMS) in a GMP-regulated manufacturing environment. - Familiarity with GMP validation lifecycle activities, including IQ/OQ/PQ/UAT testing and associated documentation standards. - Strong written and verbal communication skills with the ability to collaborate across Quality, IT, and Manufacturing stakeholder groups. Preferred Skills & Experience: - Experience with Manufacturing Execution Systems (preferably Syncade), including recipe authoring and EBR/RBE workflows. - Experience authoring GMP system lifecycle documents (URS, FS, DS) and technical writing in a regulated environment. - Familiarity with ValGenesis, HP ALM, or similar validation management and defect tracking tools. - Experience integrating labeling systems with MES, ERP (SAP/Oracle), or LIMS platforms. - Knowledge of VBScript, JavaScript, or similar scripting languages used within MES or labeling automation workflows. - Understanding of ISA-88/ISA-95 manufacturing standards. Education: - Bachelor's degree in Computer Science, Information Technology, Engineering, or a related technical or scientific discipline required. Experience: - 3-5 years of relevant experience in pharmaceutical, biotech, or a similarly regulated manufacturing environment, with demonstrated hands-on experience in labeling system development, SQL/XML-based data solutions, and support of GMP manufacturing systems. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.