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Job DescriptionJob DescriptionSummary
Notes from the manager
I am in need of a engineer who can do compliance reviews on systems that have had FDA issues found. This candidate will be required to have some software development. Java is the skill but we may consider candidates with other development .
Note: 2 Contractors will be 100% assigned to FDA audit response mitigation activities for 12 months.
Requirements
Minimum Required Education:
Bachelor's / Master's Degree in Electronics Engineering, Computer Science, Data, Manufacturing Engineering, or equivalent.
Minimum Required Experience:
Minimum 2 years of experience with a Bachelor's in areas such as Manufacturing/Operations, Engineering, Industrial Engineering, Systems Engineering, Production Engineering, Computer Science, or Cost Engineering or equivalent.
Education:
Masters degree in Computer Science, Data Engineering, Mechanical Engineering, Electronics Engineering, Manufacturing Engineering, or equivalent.
Experience:
1-3 years of experience with a Master's degree in Computer Science, Data Engineering, Mechanical Engineering, Electronics Engineering, Manufacturing Engineering, or equivalent..
Certification:
Lean Six Sigma or equivalent.
Skills:
Manufacturing Principles
SAP-ME experience
SAP ERP experience
Basic to strong ABAP skills and understanding of SAP PM, IDocs, and RFCs
Java (SAP ME SDK), with some exposure to MII transactions and XML/XSLT.
Python or C# service development, plus experience with APIs/web services and the SAP NetWeaver RFC SDK.
Microsoft Azure/Databricks experience
Equipment Installations
Product Lifecycle Management (PLM)
Process Improvements
Lean Manufacturing
Business Acumen
Six Sigma
Regulatory Compliance
CAPA Methodologies
Project Management
Skills
Basic to strong ABAP skills and understanding of SAP PM, IDocs, and RFCs Java (SAP ME SDK), with some exposure to MII transactions and XML/XSLT. Python or C# service development, plus experience with APIs/web services and the SAP NetWeaver RFC SDK.
Responsibilities
Develop solutions to improve the handshake between the ERP and MES systems.
Collaborate with Philips central teams on innovative solutions that improve the compliance of manufacturing processes.
Reviews and updates quality control plans and work instructions, maintaining adherence to embedded quality standards, including compliance with safety, regulatory, environmental, and legal requirements, as well as company General Business principles and other relevant policies.
Ensures precise installation of equipment and provides advanced support during the ramp-up phase of specific processes at the site, ensuring seamless integration of new machinery and facilitating the transition to full-scale production while adhering to quality and safety standards.
Provides advanced input from the factory perspective during the sign-off at the SR milestone and project closure, ensuring that manufacturing considerations are adequately addressed and contributing to the successful completion of the project with a focus on quality, efficiency, and adherence to manufacturing standards and requirements.
Ensures design changes are implemented throughout the lifecycle management process (LCM) to improve product functionality, efficiency, and quality, ensuring seamless integration and compliance with industry standards and regulatory requirements.
Implements enhancements in manufacturing processes, tools, and equipment to drive quality and efficiency improvements, and monitors the performance of processes, tools, and equipment following project handover, ensuring seamless continuity and addressing any operational challenges that arise.
Applies lean manufacturing principles, employing methodologies to streamline production processes, minimize waste, optimize resource utilization, and enhance overall efficiency within the manufacturing environment.
Notes from the manager
I am in need of a engineer who can do compliance reviews on systems that have had FDA issues found. This candidate will be required to have some software development. Java is the skill but we may consider candidates with other development .
Note: 2 Contractors will be 100% assigned to FDA audit response mitigation activities for 12 months.
Requirements
Minimum Required Education:
Bachelor's / Master's Degree in Electronics Engineering, Computer Science, Data, Manufacturing Engineering, or equivalent.
Minimum Required Experience:
Minimum 2 years of experience with a Bachelor's in areas such as Manufacturing/Operations, Engineering, Industrial Engineering, Systems Engineering, Production Engineering, Computer Science, or Cost Engineering or equivalent.
Education:
Masters degree in Computer Science, Data Engineering, Mechanical Engineering, Electronics Engineering, Manufacturing Engineering, or equivalent.
Experience:
1-3 years of experience with a Master's degree in Computer Science, Data Engineering, Mechanical Engineering, Electronics Engineering, Manufacturing Engineering, or equivalent..
Certification:
Lean Six Sigma or equivalent.
Skills:
Manufacturing Principles
SAP-ME experience
SAP ERP experience
Basic to strong ABAP skills and understanding of SAP PM, IDocs, and RFCs
Java (SAP ME SDK), with some exposure to MII transactions and XML/XSLT.
Python or C# service development, plus experience with APIs/web services and the SAP NetWeaver RFC SDK.
Microsoft Azure/Databricks experience
Equipment Installations
Product Lifecycle Management (PLM)
Process Improvements
Lean Manufacturing
Business Acumen
Six Sigma
Regulatory Compliance
CAPA Methodologies
Project Management
Skills
Basic to strong ABAP skills and understanding of SAP PM, IDocs, and RFCs Java (SAP ME SDK), with some exposure to MII transactions and XML/XSLT. Python or C# service development, plus experience with APIs/web services and the SAP NetWeaver RFC SDK.
Responsibilities
Develop solutions to improve the handshake between the ERP and MES systems.
Collaborate with Philips central teams on innovative solutions that improve the compliance of manufacturing processes.
Reviews and updates quality control plans and work instructions, maintaining adherence to embedded quality standards, including compliance with safety, regulatory, environmental, and legal requirements, as well as company General Business principles and other relevant policies.
Ensures precise installation of equipment and provides advanced support during the ramp-up phase of specific processes at the site, ensuring seamless integration of new machinery and facilitating the transition to full-scale production while adhering to quality and safety standards.
Provides advanced input from the factory perspective during the sign-off at the SR milestone and project closure, ensuring that manufacturing considerations are adequately addressed and contributing to the successful completion of the project with a focus on quality, efficiency, and adherence to manufacturing standards and requirements.
Ensures design changes are implemented throughout the lifecycle management process (LCM) to improve product functionality, efficiency, and quality, ensuring seamless integration and compliance with industry standards and regulatory requirements.
Implements enhancements in manufacturing processes, tools, and equipment to drive quality and efficiency improvements, and monitors the performance of processes, tools, and equipment following project handover, ensuring seamless continuity and addressing any operational challenges that arise.
Applies lean manufacturing principles, employing methodologies to streamline production processes, minimize waste, optimize resource utilization, and enhance overall efficiency within the manufacturing environment.