Product Owner/Technical Business Analyst
1 month ago
Beckman Coulter Life Sciences is a leading provider of life sciences solutions, and we are seeking a highly skilled Technical Business Analyst to join our team. As a Technical Business Analyst, you will play a critical role in driving the success of our Manufacturing Execution System (MES) program deployment.
Key Responsibilities:- Engage with stakeholders to understand their business goals and end-to-end workflows for AVEVA MES implementation.
- Translate business workflows into user stories, use cases, and interface specifications for the implementation team.
- Prioritize user stories into the right sequence of projects and releases for the team to implement.
- Understand and follow the prescribed governance process and workflow development methodology.
- Follow relevant IT processes and practices for changes and incidents, ensuring completeness of all documentation and plans.
- Own the Quality Assurance aspects – ensure that implementation of new requirements into system designs and configuration match the outcome from user stories.
- Support Project Lead with deployment and administration of QA and production environments.
- Provide L2 technical support with triaging and debugging user issues with Aveva MES modules and associated interfaces.
- Keep abreast of AVEVA products/tech. roadmap to understand impacts and plan for upgrades.
- Learn and work with Danaher Business Systems methodologies for continuous process improvement; proactively suggesting solutions to business users
- 7 years of overall IT applications implementation experience with at least years in the MES domain
- 5+ years of hands-on experience in deploying and supporting AVEVA modules
- Strong knowledge of AVEVA MES (formerly Wonderware MES) and Work Tasks (Workflow Management formerly Skelta BPM). Forecasted modules used are System Platform, Skelta WF, Skelta Portal, Reporting services, Alpana and Operation
- Should have implemented MES, Manufacturing IT, related products in Life Science, Medical segment, or any other domain.
- Modern software development methodologies including Agile and Scrum
- Solid problem-solving and critical thinking skills with attention to detail
- Familiarity with Manufacturing Batch/Device History Records
- Should have good presentation and communication skills.
- FDA Validation experience with CFR 21 Part 11, Annex 11, GAMP5, and regulations and guidelines pertinent to Data Integrity.
- Knowledge and experience with Good Documentation Practices and Good Manufacturing Practices
- Experience in Medical Device manufacturing
- Experience with Danaher Business Systems principles.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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