Product Owner

In this Role, Your Responsibilities Will Be:

• Act as the primary liaison between business stakeholders (e.g., manufacturing, quality assurance, compliance teams) 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.
• Work with Product Manager to define features for development.
• Own the team’s backlog and prioritize user stories to meet the needs of the business and our customer in the most effective way possible.
• 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.
• Support documentation and validation efforts required for regulatory audits.
  

Who You Are:

For This Role, You Will Need:

• Bachelor’s degree in engineering, Computer Science, or a related technical field.
• The ability to clearly communicate technical topics at a variety of levels to different audiences within the department
• Self-motivated with the ability to work independently and on a team
• Excellent communication and time management skills
  

Qualifications:

• Bachelor’s degree in Computer Science, Engineering, or a Master’s degree with 8+ years of experience.
• 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).
• Excellent communication, stakeholder management, and problem-solving skills.
• Ability to translate complex regulatory and business requirements into technical user stories.
• Detail-oriented with a strong sense of ownership and commitment to product quality.
• Prior experience with MES products or pharmaceutical digital transformation projects is highly desirable.
  

Preferred Qualifications that Set You Apart:

• 6 - 10 years of progressive Life Science experience, including five (5) years of recipe authoring experience
• Experience in Product Development
• Experience working in an Agile Development environment
• Solid domain knowledge of Life Science Processes
• Certification as a Scrum Product Owner (CSPO) or equivalent Agile certification.