Application Developer MESLabelling Systems

Job Title: Labeling Developer

Location: Bangalore (Hybrid)

About 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 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 companys 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:

• Bachelors 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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.