GxP Instrument Systems Engineer- Norwood, MA

Headquarters: Fully Remote - US URL: http://ahutech.com

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Job Description CONTEXTThe 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 RESPONSIBILITIESCollaborate 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 upgradesTranslate system/equipment/data integration requirements from various teams into deployable Digital Laboratory System solutionsManage change control for regulatory Digital documentation (SOPs, work instructions, etc.) required to demonstrate appropriate compliancePartner with stakeholders to validate and integrate key systems into the connected instrument pipeline, future robotics/automation capabilities and AI initiativesIdentify opportunities to optimize current processes and implement upgraded solutionsEnsure GMP compliance in the design, delivery and maintenance of all systemsMaintain inspection readiness throughout the duration of the projectParticipate in internal and external audits as requiredREQUIREMENTSBachelor s degree or equivalent in science, engineering or computer science discipline5 to 7+ years experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a biopharmaceutical GMP environmentDirect experience with automation solutions such as Hamilton VenusExperience working with advanced automated laboratory analytical systems such as Waters Andrew+, Oxford Nanopore, and Hamilton Venus liquid handlersExperience with GAMP and GxP compliance regulationExperience with data integrity regulations, instrument integration and laboratory digital workflow optimizationExperience with Digital systems hosted in the cloud and an understanding of connectivity between on-prem systems and SAAS/CloudStrong understanding of core laboratory systems, related processes, and quality management workflowsAbility to work independently and in a team setting, with the ability to effectively communicate cross-functionallyAbility to support multiple concurrent projects in a fast-paced environmentStrong interpersonal and relationship-building skillsLOCATIONOn-site 3-4 days/week between Marlborough, MA and Norwood, MA

This is a remote position.

About Us AHU Technologies INC. is an IT consulting and permanent staffing firm that meets and exceeds the evolving IT service needs of leading corporations within the United States. We have been providing IT solutions to customers from different industry sectors, helping them control costs and release internal resources to focus on strategic issues. AHU Technologies INC. was co-founded by visionary young techno-commercial entrepreneurs who remain as our principal consultants. Maintaining working relationships with a cadre of other highly skilled independent consultants, we have a growing number of resources available for development projects. We are currently working on Various projects such as media entertainment, ERP Solutions, data warehousing, Web Applications, Telecommunications and medical to our clients all over the world.

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