Computer Systems Validation Engineer

The Role Moderna is seeking a GxP Systems Engineer who will serve a key role supporting the Validation, Delivery and Administration of the GxP laboratory benchtop computerized systems and Enterprise systems. This role will be a member of the Digital Quality team and requires both strong intellectual agility and hands-on technical skills. Activities will also include authoring and executing test protocols.

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 QC computerized Lab Benchtop Systems (HIAC, FTIR, TOC, Bioanlyzers, Sequencers, etc.) and Enterprise Instrumentation Systems (Chromeleon Chromatography Data System, Scientific Data Management System (LogiLab), CFR Gateway (LogiLab), SoftMax Pro, etc.) including optimizations, compliance enhancements, support, maintenance updates and version upgrades.

• Translate system/equipment/data integration requirements from various Digital and Businessteams to be able to deploy the appropriate Digital Lab System solution.

• 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 and approve lifecycle documents like system impact assessment, regulatory applicability, and criticality assessments, ERES assessments, URS, FRS, System Configuration/Design Specifications, System Administration SOP, etc. and execute test scripts following cGxP.

• Provide support to the QC labs for the Benchtop and Enterprise computer systems as system administrator.

• Assist with incidents requiring troubleshooting and be the subject matter expert to investigate, troubleshoot, find resolution, and implement the resolution.

• Generate Periodic Reviews, system audit trail reviews, and user access reviews for the systems and assist in periodic reviews performed by other SME’s.

• 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.

• On site presence required with possible travel between regional sites.

• Additional duties as may be assigned from time to time.

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

• A bachelor’s degree in STEM or another relevant academic discipline

• A minimum of 4 years’ experience working in a controlled cGxP environment; a combination of education and experience may be considered with an MS degree.

• Experience authoring and reviewing computer system validation lifecycle documents.

• Experience with Document Management, QMS, ServiceNow and System Administration activities.

• Experience authoring and executing validation lifecycle deliverables within an SDLC tool (KNEAT).

• Experience writing change controls and deviations/CAPAs utilizing GxP workflows. Here’s What You’ll Bring to the Table (Preferred Qualifications)

• 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. is preferred.

• 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.