GXP Instrument Systems Engineer

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.

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 One Lab, etc.) and Enterprise Instrumentation Systems (Chrome Leon Chromatography Data System, Scientific Data Management System (Log iLab), CFR Gateway (Log iLab), Soft Max 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 with advanced automated laboratory analytical systems such as Waters Andrew+, Oxford Nanopore, and Hamilton Venus liquid handlers.
• Experience with GAMP and GxP compliance regulation.
• Experience with data integrity regulations, instrument integration and laboratory digital workflow optimization.
• Experience with Digital systems hosted in the cloud and an understanding of connectivity between on-prem systems and SAAS/Cloud.
• Strong understanding of core laboratory systems, related processes, and quality management workflows.
• Ability to work independently and in a team setting, with the ability to effectively communicate cross-functionally.
• Ability to support multiple concurrent projects in a fast-paced environment.
• Strong interpersonal and relationship-building skills.