• Reedsville, PA
  • $55–$57 Per Hour
  • Quick Apply
6 days ago

Job Description

Job Summary:
  • 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).
Education Requirements:
  • 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.
Experience Requirements:
  • 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.
Certifications (Preferred):
  • Lean Six Sigma or equivalent.
Preferred Skills:
  • 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 NetWeaver 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.
Responsibilities:
  • 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.

Numbers & Facts

LocationReedsville, PA
Salary$55–$57 Per Hour

Skills

  • ABAP Programming Languageunmatched
  • Application Programming Interface (API)unmatched
  • Business Skillsunmatched
  • Computer Scienceunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cost Engineeringunmatched
  • ERP (Enterprise Resource Planning)unmatched
  • Electronic Engineeringunmatched
  • Environmental Lawunmatched
  • FDA (Food and Drug Administration)unmatched
  • Javaunmatched
  • Lean Manufacturingunmatched
  • Legal Standardsunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Engineeringunmatched
  • Manufacturing Execution Systems (MES)unmatched
  • Manufacturing Methodsunmatched
  • Manufacturing Operationsunmatched
  • Manufacturing Requirementsunmatched
  • Manufacturing/Industrial Processesunmatched
  • Microsoft C# (C Sharp)unmatched
  • Microsoft Windows Azureunmatched
  • Process Improvementunmatched
  • Product Designunmatched
  • Product Lifecycle Managementunmatched
  • Programming Languagesunmatched
  • Project/Program Managementunmatched
  • Python Programming/Scripting Languageunmatched
  • Quality Controlunmatched
  • RFCunmatched
  • Regulatory Complianceunmatched
  • SAPunmatched
  • SAP ECC (fka SAP R/3 and SAP ERP)unmatched
  • SAP NetWeaverunmatched
  • Safety Complianceunmatched
  • Six Sigmaunmatched
  • Software Developmentunmatched
  • Team Playerunmatched
  • Tool and Die Manufacturingunmatched
  • Web Servicesunmatched
  • XML (EXtensible Markup Language)unmatched
  • XSLT (Extensible Stylesheet Language Translation)unmatched

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