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Associate GxP Systems Engineer
2 months ago
We are seeking an Associate GxP Systems Engineer to support the validation, delivery, and administration of GxP laboratory benchtop computerized systems and Enterprise systems. The ideal candidate will have a strong background in computer systems validation, experience working in a controlled cGxP environment, and excellent communication skills.
Key Responsibilities- Assist in troubleshooting issues with systems, update configuration, and assist with deployment of systems.
- Participate in generating and maintaining necessary supporting applications, documents, and procedures.
- Author and execute test protocols.
- Drive system validation activities in conjunction with Business, IT, Equipment, Validation, and QA partners.
- Review and approve lifecycle documents, such as impact assessments, regulatory applicability, and criticality assessments.
- Provide support to the QC labs for 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.
- 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).
Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop novel therapeutics and vaccines. We are committed to advancing the field of mRNA technology and improving the lives of patients worldwide.
We are proud to be an equal opportunity employer and are committed to diversity, equity, and inclusion in the workplace. We offer a comprehensive benefits package, including medical, dental, and vision coverage, as well as a 401(k) plan and paid time off.
If you are passionate about advancing the field of mRNA technology and improving the lives of patients, we encourage you to apply for this exciting opportunity.
