Position Summary
The Senior Engineer will provide technical and operational support for manufacturing and process improvement initiatives within a regulated environment. This role is responsible for leveraging engineering principles, data analytics, digital solutions, and continuous improvement methodologies to enhance manufacturing performance, operational efficiency, and compliance. The ideal candidate is a self-driven professional who can navigate ambiguous business needs and translate operational challenges into practical digital tools, dashboards, and sustainable process improvements.

Key Responsibilities
• Analyze manufacturing and operational data to identify trends, opportunities, and improvement initiatives.
• Design, develop, and maintain dashboards, reports, and digital tools that support business and manufacturing objectives.
• Support process improvement projects through data-driven analysis and engineering solutions.
• Generate and maintain GMP-compliant documentation and support validation-related activities as required.
• Collaborate with cross-functional teams to support manufacturing operations, engineering studies, process characterization, PPQ activities, and manufacturing readiness efforts.
• Utilize automation and digital technologies to improve efficiency, reduce manual processes, and enhance operational effectiveness.
• Translate complex operational challenges into practical and scalable technical solutions.
• Support continuous improvement initiatives to drive operational performance, compliance, and reliability.
• Communicate technical findings, recommendations, and project progress to stakeholders and leadership.

Minimum Qualifications

• Doctorate Degree in Engineering; OR
• Master's Degree in Engineering plus two (2) years of engineering experience; OR
• Bachelor's Degree in Engineering plus four (4) years of engineering experience.

Preferred Qualifications

• Experience with data analysis, visualization tools, and dashboard development.
• Knowledge of statistical evaluation and data-driven decision-making.
• Experience authoring and supporting GMP documentation.
• Understanding of validation principles and process improvement methodologies.
• Experience with AI-enabled, automation, or digitalization tools such as Python, Codex, Power Automate, SQL, and/or VBA.
• Experience supporting Drug Product manufacturing operations.
• Exposure to characterization studies, engineering runs, process performance qualification (PPQ), validation activities, and manufacturing readiness initiatives.
• Ability to identify opportunities for operational excellence and implement sustainable solutions.