Senior Business Analyst, MES
- Philadelphia, PA
The Senior Business Analyst is responsible for filling the role of a Manufacturing Execution System (MES) Senior Business Analyst/Modeler within a life sciences environment. This is a functional role and will be critical in helping to develop business requirements, testing, and assisting with maintaining some changes and modifications to the MES application.
This role will work closely with several technical and business partner groups to support the application. The MES Senior BA/Modeler will be instrumental in assisting all management levels to make informed business decisions from a functional perspective and drive efficiencies. This role will also assist the IT Senior Director with the overall lifecycle management of the application to support a range of regulated processes and activities across cell and gene therapy manufacturing. The role requires the ability to work at a fast pace.
Experience / Education
- Serve as the primary liaison between the IT and manufacturing operations teams
- Assist in evaluating business needs, research, and performing impact analysis of new requirements or changes.
- Lead working sessions with business end users, IT representatives, and vendors to determine and document both current state and future state processes, workflow diagrams, and requirements.
- Elicit, analyze, validate, and document business and functional requirements from end users to achieve their desired results for system features or process changes.
- Provide functional and modeling support for the MES platform.
- Architect solutions to solve business problems by the most efficient means possible.
- Follow change control, validation procedures, and documentation.
- Act as an escalation point for related MES help desk cases to ensure timely and accurate closure of issues.
- Develop and maintain the corporate knowledge base for MES and ancillary applications and associated environments.
- Be an expert on the MES application system's functional capabilities and usage.
- Develop test cases and perform comprehensive functional testing.
- Develop system & user acceptance testing scenarios based on the business process and requirements.
- Participate in the planning, scheduling, and oversight of user acceptance testing (UAT).
- Demonstrate strong customer service skills and a calm, positive, professional demeanor to accurately identify and resolve user issues.
- Work in partnership with stakeholders to improve business processes impacted by technology changes. Take on complex, high-profile projects.
Knowledge / Skills / Abilities:
- Bachelor’s degree in computer science/Information Systems, Life Sciences, or equivalent industry experience.
- 7+ years of relevant experience as a MES Modeler within an MES Systems Environment.
- Demonstrated experience with SDLC processes, iterative development methodologies, and computer systems validation (CSV)
- 7+ years of experience performing business analysis and supporting major business applications.
- Prior experience in supporting an MES or Manufacturing operations management systems required (previous experience working as a modeler using WERUM PASX MES Suite preferred).
- 3+ years of experience with relational database technologies.
- Knowledge of production scheduling, quality management, work order process flow, and BOM management strongly preferred.
- Having additional knowledge behind potential integrations (internal and external) to an MES system (is a nice to have skill).
- Experience creating, configuring, testing, reviewing, analyzing, and/or approving electronic Master Batch Records (MBR) in the Manufacturing Execution System (MES).
- Qualification (OQ), Process Qualification (PQ), and configuration design specification in accordance with CFR 21 would be helpful.
Friday, September 22, 2023