Empower Master Data Analyst

Overview

Design, configure, implement and maintain global method templates and Empower master data (Custom Fields, Report Methods, View Filters and related methods) in the Empower Chromatography Data System, in line with approved method requirements, global procedures, data standards and SDLC requirements.

What you'll do

• Responsible for Empower Master Data Management, including creation, configuration, maintenance and update of Custom Fields, Report Methods, View Filters and other associated Empower methods.
• Analyze test method requirements and translate them into appropriate Empower technical requirements for configuration.
• Prepare technical assessments for proposed Empower changes, develop detailed system requirements, and document changes within applicable site or global change control systems.
• Manage assigned Empower changes through the applicable change control and system lifecycle processes, ensuring documentation, traceability and compliance.
• Execute technical configuration and master data changes based on approved requirements and technical assessments.
• Review and assess Empower configurations for alignment with approved requirements, design principles and global data standards.
• Support the development and maintenance of standardized Empower configurations and drive master data standardization and process harmonization across sites.
• Perform second-person reviews of Empower configurations, change control documentation, requirements and supporting source documentation for accuracy, completeness, data integrity and compliance.
• Provide technical support and guidance for LIMS Empower interfaces and Digital Method builds, including troubleshooting and assessment of configuration or integration-related issues.
• Develop and execute test scripts and validation protocols supporting Empower configuration and system changes.
• Collaborate with site and global teams to confirm requirements, technical design, configuration, testing and implementation readiness.
• Partner with site Empower analysts, Global Empower teams, laboratory users, validation teams, and LIMS and laboratory instrumentation teams to deliver solutions in a timely and compliant manner.
• Investigate and support resolution of Empower-related technical issues, configuration discrepancies and master data challenges.
• Effectively manage multiple assignments and priorities to meet committed implementation dates.
• Build strong relationships with customers and stakeholders through responsive communication, technical expertise and consistent delivery.
• Work independently within defined objectives while proactively identifying and resolving technical or delivery challenges.

What you'll need

• Bachelor's degree or higher in Computer Science, Biology, Microbiology, Pharmacy, Chemistry, Engineering, or a related scientific or technical field; or equivalent relevant experience.
• Minimum of 4 years of hands-on Empower experience within a pharmaceutical or similarly regulated environment.
• Experience developing Empower Custom Fields and Reporting Methods to support laboratory testing such as Assay, Dissolution and Content Uniformity.
• Demonstrated hands-on experience configuring and maintaining Empower configuration, including Instrument Methods, Processing Methods, Sample Set Methods, View Filters, Custom Fields and Report Methods.
• Experience supporting integration between Empower and external laboratory systems such as LabWare LIMS.
• Understanding of regulatory and data integrity expectations applicable to computerized laboratory systems used in the manufacture and testing of pharmaceutical, vaccine, biological or sterile products.
• Experience working within System Development Life Cycle (SDLC) and computerized system validation processes.
• Ability to develop and execute test scripts and validation protocols and document results in accordance with established procedures.
• Strong technical aptitude for computerized laboratory systems, data analysis, troubleshooting and method/configuration evaluation.
• Strong analytical and problem-solving skills with a high level of attention to detail.
• Demonstrated ability to work effectively across geographically distributed teams and multiple stakeholder groups.
• Flexibility to adjust working hours, up to approximately 25% of the work week when required, to support collaboration with U.S. East Coast project teams, particularly during onboarding, training and critical implementation activities.

Nice to have

• Preferably Empower 3 FR5 or higher.
• Experience with LabWare LIMS, including laboratory master data management and integration with Empower.
• Experience supporting Empower in a multi-site or global pharmaceutical environment.
• Familiarity with electronic document management, electronic change control and other GxP-compliant platforms.
• Experience with databases and data analysis technologies, particularly Oracle and SQL.

Details

• Location: Pune, Maharashtra, India (Wework).
• Work arrangement: Hybrid.
• Employee status: Regular.
• Travel requirements: Flexible.
• Working hours may extend up to approximately 25% of the work week to support U.S. East Coast project teams.