Product Owner (m/w/d)

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:

You are a customer and product focused individual with a solid understanding of Life Science processes and pharmaceutical recipes. You are a balanced decision maker who crafts solutions which align requirements of both customers and the organization. You excel at planning and prioritizing work needed to meet commitments and can rally a team to meet those commitments. You have expert communication skills and can relay technical and non-technical information simply and clearly to a wide range of audiences.

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.