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Associate GxP Systems Engineer
2 months ago
Moderna is seeking a highly skilled Associate GxP Systems Engineer to support the validation, delivery, and administration of laboratory benchtop computerized systems and Enterprise systems. As a key member of the GxP Systems team, you will play a critical role in ensuring the quality and integrity of our systems.
Key Responsibilities- Drive system validation activities in conjunction with Business, IT, Equipment, Validation, and QA partners to implement new systems, perform system life cycle upgrades, and break fixes required as part of incidents.
- Work independently to author/update System Configuration/Design Specifications, System Administration SOP, execute test scripts following cGxP.
- Review and approve lifecycle documents like impact assessment, regulatory applicability, and criticality assessments, ERES assessments, etc.
- Provide support to the QC labs for the Benchtop and Enterprise computer systems as a system administrator.
- Be the first point of contact with Business and help resolve incident tickets.
- Fulfill access requests for Enterprise computer systems.
- Assist with incidents requiring troubleshooting and be the subject matter expert to investigate, troubleshoot, find resolution, and implement the resolution.
- Generate Periodic Reviews for the systems and assist in periodic reviews performed by other SMEs.
- Work with the Lab Automation team to interface the standalone systems with our SDMS and LIMS as required.
- Assist in evaluation or product enhancements and capabilities as required.
- A bachelor's degree in STEM or another relevant academic discipline.
- A minimum of 6 years with a MS degree, or 8+ with a bachelor's degree; a combination of education and experience may be considered.
- Experience authoring and reviewing computer system validation lifecycle documents.
- Prior experience in working in a controlled cGxP environment.
- Experience with Document Management, QMS, ServiceNow, and System Administration activities.
- Experience authoring and executing validation lifecycle deliverables.
- Experience writing change controls and deviations/CAPAs utilizing GxP workflows.
- Experience with Benchtop lab computerized systems like TOC, Bioanalyzers, Spectramax/Softmax, etc.
- Experience with Enterprise Instrumentation Systems such as Chromeleon Chromatography Data System, Mettler LabX, etc.
- Experience working in life sciences, pharma/biotech, or high-tech industries with a preference for experience in one or more of eCommerce, data/machine learning platforms, or cloud infrastructure.
- Experience in a regulated environment.
- Experience working in a matrixed organization.
- Experience working in a fast-paced environment requiring quality contribution on multiple critical projects.
- Demonstrated ability to work independently and collaboratively in cross-functional teams and open to learn and adapt to changing demands.
- Strong communication skills (verbal and written).
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
- Experience working with laboratory instrumentation connectivity and data.
- Familiarity with Computer Systems Validation standards and deliverables.
Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop vaccines and therapeutics. We are committed to making a positive impact on society and are seeking talented individuals to join our team.
We offer a comprehensive benefits package, including medical, dental, and vision coverage, flexible spending accounts, and a 401(k) match. We also offer a generous paid time off policy, including vacation, sick time, and holidays, as well as a discretionary year-end shutdown and paid sabbatical after 5 years.
Moderna is an equal opportunity employer and is committed to diversity and inclusion. We welcome applications from qualified candidates of all backgrounds and perspectives.
