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:

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.