Act as the primary liaison between business stakeholders and the engineering/development team for MES product initiatives.
Define, prioritize, and maintain the product backlog to align with business goals.
Collaborate with the development team to define objectives and ensure the team remains focused on meeting those objectives.
Own the team’s backlog and prioritize user stories to meet the needs of the business and our customer.
Work closely with the Scrum Masters, DevOps, and development teams to identify, manage, and coordinate dependencies with other teams.
Actively seek feedback from business stakeholders and relay it to the team.
Ensure that MES product features support compliance with 21 CFR Part 11, GMP, and other relevant pharmaceutical regulations.
Assist in risk management and mitigation strategies related to MES functionality.
Requirements
Bachelor’s degree in engineering, Computer Science, or a related technical field.
Proven experience (3+ years) as a Product Owner, Business Analyst, or similar role in pharmaceutical manufacturing or life sciences software development.
Strong knowledge of MES systems and pharmaceutical manufacturing workflows.
Familiarity with regulatory requirements such as FDA 21 CFR Part 11, GMP, GAMP5 guidelines.
Experience working with Agile software development teams and tools (e.g., Jira, Confluence).
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