Andor Tech
Website:
andortech.com
Job details:
About the Role
The Digital Functional Analyst will play a crucial role in translating the roadmap into functional features and documentation for developers, ensuring alignment with business and operational needs.
Responsibilities
- To translate the roadmap into functional features (and documentation) for the developers.
- Support functional analysis and requirements gathering to define Sentinel capabilities in line with business and operational needs.
- Enable harmonization and integration of manufacturing data from diverse source systems into the Sentinel platform, ensuring unified SPC monitoring and analysis.
- Ensure compliance with GxP regulations and provide technical expertise in manufacturing process monitoring and SPC methodologies.
- Contribute to the GxP documentation of the project, ensuring alignment with regulatory and quality standards.
- Collaborate with the Product Owner (PO), UX/UI designers, and the development team to deliver tailored solutions for both site-specific and global requirements, ensuring data consistency and regulatory compliance.
- Collaborate with UX/UI designers and the Product Owner to define user workflows, shape functional requirements, and continuously optimize platform usability and user experience.
- Create, review, and maintain functional requirements, acceptance criteria, and technical documentation in full alignment with GxP compliance standards and internal quality processes.
- Validate technical designs, Sentinel configurations, and dashboards to ensure strict adherence to GxP and applicable regulatory requirements throughout the project lifecycle.
- Work closely with the Product Owner, Business System Owner, and technical experts to document and refine backlog items, ensuring clarity and actionability for the development team.
- Lead technical discussions, facilitate cross-functional alignment, and provide subject-matter expertise on Sentinel processes, SPC methodologies, and manufacturing data requirements.
- Ensure consistent alignment across teams on project goals, milestones, timelines, and deliverables, proactively identifying and addressing risks or dependencies.
Qualifications
- 5-7+ years of experience in development (backend and frontend).
- 3-5 years of experience as a functional analyst.
- Must have knowledge in GxP (GMP) environment, in Jira and Xray, SQL.
- Must be fluent in English.
Required Skills
- Strong expertise in manufacturing parameter contextualization and process-oriented data analysis.
- Solid SQL expertise, including query writing and optimization for data extraction and analysis.
- Deep expertise in GxP compliance in manufacturing environments, including electronic records management, audit trail requirements, and system validations standards.
- Proven expertise with pharmaceutical manufacturing validation protocols and regulatory documentation practices.
- Demonstrated expertise working within Agile development teams, including sprint planning, backlog refinement, and stakeholder collaboration.
- Expertise in gathering and analyzing user requirements from diverse manufacturing roles (operators, engineers, quality managers).
- Expertise in role-based access design and manufacturing workflow optimization.
- Expertise in translating manufacturing processes into functional system requirements.
Preferred Skills
- Knowledge in data analysis and UX/UI design.
- Expertise of SPC methodologies, control chart applications, and manufacturing workflows.
- Expertise in the use of Snowflake as a cloud data platform.
- Expertise in statistics calculation.
- Expertise in Continued Process Verification (CPV), Process Monitoring (PrM), Environmental and Personnel Monitoring (EM/PM), and Analytical Lifecycle Management within regulated pharmaceutical environments.
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