GXP System Engineer

The Role

Moderna is seeking a GxP Systems Engineer, who will be responsible for the design, deployment and management of our expanding portfolio of first-in-kind automation and digital enterprise instrumentation systems that support the Quality Control GMP laboratories and system integration with our connected Digital platforms. This role will be a member of the Digital Quality team and requires both strong intellectual agility and hands-on technical skills.

Who You Are:

You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency. You thrive in a fast-paced environment and are comfortable rolling up your sleeves – if a process doesn’t exist yet, you define it. You collaborate well amongst a team of expert peers.

Here’s What You’ll Do

• Collaborate with a team of internal and external business analysts and other software/automation engineers in the complete product lifecycle management of various Digital Quality Automation Systems (Hamilton Venus, Scitara DLX, etc.) and Standalone Analytical Instrumentation (SpectraMax M5, Hamilton Liquid Pipetting systems, etc.) including implementation, optimization, support, maintenance updates and version upgrades.
• Translate system/equipment/data integration requirements from various Digital and Business teams to be able to deploy the appropriate Digital Lab System solution in a GMP environment.
• Manage or assist in necessary change control/regulatory Digital documentation (living documents, SOPs, work instructions, KB articles, etc.) required to demonstrate appropriate compliance.
• Partner with digital stakeholders to ensure successful validation and integration of key systems into the connected instrument pipeline, future robotics/automation capabilities, and any artificial intelligence initiatives.
• Foster a culture of innovation within the team and with stakeholders to challenge the status quo leveraging both new technologies and creative solutions within existing systems.
• Apply an operational excellence mindset to help Identify, devise and recommend new opportunities to optimize current processes.
• Ensure GMP compliance is built into the design, delivery and maintenance of all systems.
• Maintain inspection readiness through adherence to internal quality policies, procedures and training.
• Participate in internal and external audits as digital quality expert for portfolio of systems.
• On-site presence is required with possible travel between regional sites.
• Additional duties may be assigned from time to time.

Here’s What You’ll Need (Minimum Qualifications)

• Bachelor’s degree or equivalent in science, engineering or computer science
• 5 to 7+ years’ experience designing, implementing, and managing life sciences Analytical Instruments in a in biopharmaceutical GMP environment
• Direct experience with automation solutions such as Hamilton Venus preferred
• Experience with Linux Ubuntu SUDO commands a plus
• Experience with GAMP and GxP compliance regulations
• Experience in laboratory systems including data integrity regulations, instrument integration, and laboratory digital workflow optimization
• Experience working with Digital systems hosted in cloud and understanding of connectivity between on-prem systems and SaaS/Cloud.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Creative/innovative/problem solver that actively drives progress
• Ability to work independently and make sound and timely decision to achieve expected results
• Strong understanding of core laboratory systems, related processes, and quality management workflows
• Strong interpersonal skills with the ability to build successful professional working relationships
• Ability to participate on multiple concurrent projects in a fast-paced environment.
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.