Product Owner
2 days ago
Job Description Job 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 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.
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