Electronic Data Collection Engineer

Contact Management • Contract • Sinking Spring, PA, US • $55 - $65 / hour • 1m ago

Leading Medical Device/ Pharmaceutical company is seeking an experienced Data Steward – Electronic Data Collection Engineer in a GMP-regulated facility. This is a three-year project within the engineering group primarily supporting process improvement and maintaining systems. You will be working with several departments and maintaining databases. Good communication skills are critical.

Key Responsibilities:

· Establish, write, and maintain electronic data collection plans and configuration documents, for process monitoring and product inspection across the site.

· Addressing issues with system and making updates and corrections as needed.

· Configure, troubleshoot, and maintain system configuration for enterprise software systems. Provide guidance to facility for use of the system. Function as the first point of contact for all system support activities.

· Maintain the local procedures for respective system data collection and maintenance. Verify and approve all requests for system access. Periodically review all users’ access.

· Maintain the technical strategy for continued process monitoring that ensures all critical process parameters and quality attributes are electronically monitored or analyzed.

· Provide input into development of automated equipment data interfaces for complex automated equipment and inspection systems.

· Support data collection qualification for new technologies. Ensure consistency with process needs defined by Manufacturing and/or Engineering.

· Perform master data changes in SAP (including BOM and Routing changes) and production and troubleshooting.

· Perform device master record changes in Veeva system

Requirements for the position:

· Bachelor’s in computer science or equivalent.

· Experience with Infinity QS is a must, preferred experience with ProFicient Infinity QS.

· Experience in FDA regulated industries preferred.

· Strong experience with enterprise software systems such as SAP, Veeva, Siemens Team Centre.

· Experience in manufacturing/ manufacturing science and technology/technical development/Quality.

· Working knowledge of applied statistics/experience in developing data collection processes a plus.

· Understanding of standard analytical and measurement systems testing.