Pursue Your Passion with Purpose

Job Title

Perform compliance reviews on systems with FDA-related issues. Contribute to FDA audit response mitigation activities (12-month assignment). Involve in some software development work (Java preferred; other programming languages may be considered).

Minimum:
Bachelor's or Master's degree in Electronics Engineering, Computer Science, Data, Manufacturing Engineering, or a related field. Preferred:
Master's degree in Computer Science, Data Engineering, Mechanical Engineering, Electronics Engineering, or Manufacturing Engineering.

Minimum: 2+ years of experience with a Bachelor's degree in Manufacturing/Operations, Engineering, Systems, Production Engineering, Computer Science, or Cost Engineering. Preferred: 1–3 years of experience with a Master's degree in a related field.

Lean Six Sigma or equivalent.

Manufacturing principles. SAP-ME and SAP ERP experience. ABAP skills with knowledge of SAP PM, IDocs, and RFCs. Java (SAP ME SDK), with exposure to MII transactions and XML/XSLT. Python or C# development, with APIs/web services and SAP Net Weaver RFC SDK. Microsoft Azure/Databricks. Equipment installations. Product Lifecycle Management (PLM). Process improvements and lean manufacturing. Business acumen. Six Sigma and CAPA methodologies.

Project management. Regulatory compliance knowledge.

Develop solutions to improve integration between ERP and MES systems. Work with central teams on innovative solutions to strengthen compliance in manufacturing processes. Review and update quality control plans and work instructions to ensure compliance with safety, regulatory, environmental, and legal standards. Ensure proper installation of equipment and support ramp-up phases for new processes. Provide factory input during project sign-offs and closures, ensuring manufacturing requirements are met.

Support design changes during product lifecycle management to enhance quality, efficiency, and compliance. Implement improvements in manufacturing processes, tools, and equipment for better efficiency and performance. Apply lean manufacturing methods to reduce waste, optimize resources, and improve overall production efficiency.