GxP Instrument Systems Engineer- Norwood, MA

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Headquarters: Fully Remote - US URL: [link] Replies within 24 hours Job Description CONTEXT The qualified GxP Instrument Systems Engineer / Senior Project Engineer will be responsible for the design, deployment and management of automation and digital enterprise instrumentation systems that support Quality Control laboratories and system integration with connected Digital platforms. JOB RESPONSIBILITIES Collaborate with Business Analysts and Software/Automation Engineers in the complete product lifecycle management of Digital Quality Automation Systems (Hamilton Venus, Waters Andrew+ with OneLab, etc.) and Enterprise Instrumentation Systems (Chromeleon Chromatography Data System, Scientific Data Management System (LogiLab), CFR Gateway (LogiLab), SoftMax Pro, MODA, etc.) including optimizations, support, maintenance updates and version upgrades Translate system/equipment/data integration requirements from various teams into deployable Digital Laboratory System solutions Manage change control for regulatory Digital documentation (SOPs, work instructions, etc.) required to demonstrate appropriate compliance Partner with stakeholders to validate and integrate key systems into the connected instrument pipeline, future robotics/automation capabilities and AI initiatives Identify opportunities to optimize current processes and implement upgraded solutions Ensure GMP compliance in the design, delivery and maintenance of all systems Maintain inspection readiness throughout the duration of the project Participate in internal and external audits as required REQUIREMENTS Bachelor’s degree or equivalent in science, engineering or computer science discipline 5 to 7+ years’ experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a biopharmaceutical GMP environment Direct experience with automation solutions such as Hamilton Venus Experience working

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