Data Engineer

Your Role

As the Data Engineer at Cell Marque STL, with minimal supervision, you will manage technology tasks and projects focused on making updates and improvements for data systems utilized for Cell Marque St. Louis. This position acts as a site subject matter expert for IT issues and aid the Operations team in administration of new site systems and/or updates to the current systems.  This position will also aid in trouble shooting of IT systems and running reports as required.  As an individual contributor this role acts as the liaison between end users (Scientists/Manufacturing/Production) and corporate IT, to guide, define, and continually enhance and maintain a robust solution across our key IT systems.

• Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual.
• Act as an expert for SAP and other digital platforms
• Troubleshoot IT system errors or investigations in real time
• Perform data analysis to guide decisions on site operational projects
• Lead projects to completion related to improvements on site systems
• Maintain accurate data in systems utilized at the site and make improvements where needed
• Oversee successful technology transfers utilizing the NPDI load file process
• Compliant with Good Manufacturing Practices (GMP)
• Learn and utilize LEAN and Six Sigma methodologies
• Implement application of data integrity regulatory guidance (e.g., FDA, MDSAP, ISO 13485, IVDR) to IT systems
• Comply with and enforce safety programs and requirements at the site
• Make recommendations in areas needing improvement and execute on projects to make improvements
• Participate in developing procedures and forms using paper-based or software-based systems as applicable
• Export and analysis from systems for site KPIs
• Additional duties as required or assigned to support the businessll Marque STL

Who You Are

Minimum Qualifications:

• Bachelor’s degree in Biology, Chemistry, Computer Science, Software Engineering or other Scientific or Technical field  
• Minimum of 5 years of experience in a technical role with ERP systems or supporting/administrating software applications or systems
• Capability to travel up to 10%

Preferred Qualifications: 

• Technical hands-on experience with SAP strongly preferred
• Ability to plan and execute projects with strong communication skills
• Capacity to create and lead presentations to summarize key activities and processes related to architecture and digital platforms
• Working knowledge and application of FDA and EU regulations (e.g. cGMP)
• Knowledge and application of data integrity regulatory guidance (e.g., FDA, MDSAP, ISO 13485, IVDR)
• Proven ability to communicate on multiple levels of the organization across the business and IT teams
• Strategic thinking and planning to translate user discussions and requirements into robust platform design and solutions
• Highly organized, conscientious, and self-motivated
• Strong organizational and time management skills
• Ability to work and make decisions independently as well as with a team
• Ability to work in technically and mentally demanding situations
• Flexibility to work across time zones and in hours to support our global organization
• Proven expertise overseeing multiple data integrations and complex requirements within analytics