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Key Responsibilities

• Develop and implement detailed testing plans, qualification strategies, and project scopes from a blank slate.
• Build and maintain the structure and documentation required for MES projects, focus on recipe qualification
• Manage project-based MES qualification activities, ensuring compliance with regulatory standards and internal quality requirements.
• Make informed and credible decisions throughout the project lifecycle, leveraging past experience to justify approaches.
• Collaborate with cross-functional teams including IT, Quality, Manufacturing, and Regulatory Affairs to ensure seamless project execution.
• Provide senior-level expertise and guidance on MES implementation best practices.
• Ensure all qualification deliverables meet quality standards and timelines.
• Act as the primary QA MES resource, focusing exclusively on MES-related validation activities.

Required Experience and Skills

• Several years of hands-on experience as a quality engineer in MES deployments or similar.
• Proven track record of project-based recipe qualification.
• Experience working with responsibility for decision making and project leadership.
• Demonstrated ability to start projects from scratch, including writing testing plans and developing strategies.
• Strong decision-making skills with a credible and confident personality.
• Deep understanding of MES systems and their validation requirements.
• Excellent communication and interpersonal skills to work effectively with diverse teams.
• Ability to work independently and manage multiple priorities in a project environment.