Data Engineer

Your Role

As the Data Engineer at Cell Marque St. Louis, 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. 

Key Responsibilities:

• Ensure compliance with regulatory requirements (MDSAP, ISO 13485, IVDR) and the site Quality Manual.
• Serve as an expert for SAP and other digital platforms.
• Troubleshoot IT system errors in real time and perform data analysis to support operational decisions.
• Lead projects aimed at improving site systems and maintain accurate data in relevant systems.
• Oversee successful technology transfers and ensure compliance with Good Manufacturing Practices (GMP).
• Utilize LEAN and Six Sigma methodologies and implement data integrity regulatory guidance in IT systems.
• Enforce safety programs and make recommendations for improvements, executing projects as needed.
• Develop procedures and forms for paper-based or software-based systems.
• Export and analyze data for site KPIs and perform additional duties as required.

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: 

• Strong technical hands-on experience with SAP is preferred.
• Ability to plan and execute projects with excellent communication skills.
• Experience in creating and leading presentations to summarize key activities related to architecture and digital platforms.
• Working knowledge of FDA and EU regulations, including cGMP.
• Familiarity with data integrity regulatory guidance (FDA, MDSAP, ISO 13485, IVDR).
• Proven ability to communicate effectively across all levels of the organization, including business and IT teams.
• Strategic thinking to translate user discussions into robust platform designs and solutions.
• Highly organized, conscientious, and self-motivated with strong time management skills.
• Ability to work independently and collaboratively within a team.
• Capacity to perform in technically and mentally demanding situations.
• Flexibility to work across time zones to support a global organization.
• Proven expertise in overseeing multiple data integrations and complex analytics requirements. Cell Marque St. Louis