Manufacturing Execution Systems Business Analyst (MES)

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The Senior Business Systems Analyst, with a primary focus on working with our global Manufacturing Execution System (MES) Pharma Suite, leads efforts to develop, implement, and optimize system recipes. Collaborating closely with process teams, business stakeholders, and cross-functional teams, the analyst ensures alignment with operational and strategic goals. This critical role drives continuous improvement in manufacturing processes and maximizes the value of our MES system for global operations. Additionally, the role involves supporting both small and large-scale projects, ensuring compliance with regulatory standards such as CFR Part 820, 21 CFR Part 11, ISO 13485, and other GxP regulations, while enhancing business processes and system utilization.

Moreover, the Senior Business Systems Analyst provides application support by responding to service desk issues, investigating problems, identifying root causes, and implementing solutions. Support Computer Systems Validation (CSV) efforts, including the development and review of validation documentation (Test Scripts, Validation Plans, IQ/OQ/PQ, etc.), and participate in system testing and validation processes. All activities are conducted in compliance with Roche and global Diagnostics standards, IT Project Methodology, and CSV rules and guidelines.

• Assists the business in the use and utilization of Business Systems; ERP/SAP, LIMS, and other systems used by Operations.

• Participates and contributes to small project requests and large (portfolio) projects, providing support for productive applications and ensuring compliance with corporate and global Roche and Diagnostics standards.

• Applies business process functional knowledge to manage and improve processes, enhancing system utilization while maintaining compliance with CFR Part 820, 21 CFR Part 11, ISO-13485, and other GxP regulations.

• Supports production applications by responding to service desk calls, tracking issues, investigating problems, determining root causes, and implementing solutions.

• Assists in projects related to Computer Systems Validation by authoring, reviewing, and consulting on validation documentation (e.g., Test Scripts, Validation Plans, IQ/OQ/PQ, and Validation Reports) and performing system testing and validation.

• Acts as the bridge between IT, business operations, and manufacturing teams, ensuring clear communication and alignment on system enhancements, issue resolution, and process improvements. Facilitates meetings and workshops to gather requirements and translate them into actionable changes.

• Identifies opportunities for system and process improvements through detailed analysis of MES data, performance metrics, and user feedback. Drives initiatives to enhance the system's capabilities, reduce downtime, and improve overall manufacturing efficiency.

• You have a Bachelor's degree in Computer Science, Information Technology or related field.

• You have 5 to 7 years of experience.

Are equivalencies acceptable?

Yes, 5 to 7 years equivalent combination of education and work-related experience.

Knowledge, Skills and Abilities

• Strong understanding of MES Pharma Suite systems, including recipe management, batch processing, and integration with ERP/LIMS required.

• Minimum of 5-7 years of experience in business systems analysis, with a focus on MES (Manufacturing Execution Systems), preferably in a pharmaceutical or regulated industry required.

• Knowledge of GMP, FDA regulations, and other relevant industry standards, preferred.

Relocation assistance is not available for this opportunity

GG: SE5

The expected salary range for this position based on the primary location of Branchburg, NJ is 76,500 - 140,000 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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