Description:
Moderna is seeking a skilled Principal Systems Engineer, Digital Lab Systems for our Harwell, England, UK location. This crucial position involves supporting and managing software solutions for laboratory equipment in Quality Control, covering the entire lifecycle of laboratory digital solutions.
Within 3 Months, You Will…
- Take charge of coordinating the delivery of bench-top laboratory systems.
- Independently develop and document system requirements, configuration specifications, and author System Administration SOPs in compliance with cGxP.
- Execute test scripts and author critical lifecycle documentation, including Impact Assessment and ERES assessments, ensuring compliance and regulatory readiness.
Within 6 Months, You Will…
- Provide robust administrative and technical support for enterprise laboratory systems such as Chromeleon, LIMS, Logilab SDMS, MODA, etc.
- Perform thorough root cause analysis for operational issues and actively participate in deviation investigations to maintain system integrity.
- Be a key representative for Digital Quality in system validation activities, liaising with IT, Validation, and QA for the implementation of new lab systems and their ongoing support.
Within 12 Months, You Will…
- Undertake periodic reviews, supporting maintenance activities for Quality Control laboratory systems to ensure operational excellence and regulatory compliance.
- Lead the implementation of system upgrades and enhancements, adapting to evolving lab requirements and technological advancements.
- Represent Digital Quality expertise in internal and external audits, maintaining the highest standards of compliance and quality assurance.