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.
LOCATION
On-site 3-4 days/week between Marlborough, MA
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
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 bio pharmaceutical 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