Description:

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 teams 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:

- Bachelors 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:

- Bachelors degree in Computer Science, Engineering, or a Masters 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.