Business Systems Optimization Specialist
2 weeks ago
About Roche
At Roche, we are a global leader in healthcare innovation. With over 100,000 people across 100 countries, we strive to push back the frontiers of healthcare. Our success is built on innovation, curiosity, and diversity.
Job Summary
We are seeking a highly skilled Senior Business Systems Analyst to join our team. This critical role will drive continuous improvement in manufacturing processes and maximize the value of our MES system for global operations.
Main Responsibilities
- Leverage expertise in MES Pharma Suite systems, including recipe management, batch processing, and integration with ERP/LIMS, to optimize manufacturing processes.
- Collaborate closely with process teams, business stakeholders, and cross-functional teams to ensure alignment with operational and strategic goals.
- Support 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.
- Provide application support by responding to service desk issues, investigating problems, identifying root causes, and implementing solutions.
- Participate in Computer Systems Validation efforts, including the development and review of validation documentation and system testing and validation processes.
Requirements
- Bachelor's degree in Computer Science, Information Technology, or related field.
- 5-7 years of experience in business systems analysis, with a focus on MES, preferably in a pharmaceutical or regulated industry.
- Knowledge of GMP, FDA regulations, and other relevant industry standards.
What We Offer
- A competitive salary range of $74,100 - $137,500 per year, based on experience and qualifications.
- Discretionary annual bonus may be available based on individual and company performance.
- Benefits package that includes health insurance, retirement plan, and paid time off.
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