Systems Engineer

Job Title : GxP Instrument Systems Engineer


Location: Norwood, MA


LOCATION
On-site 3-4 days/week between Marlborough, MA and Norwood, MA


Skills: Data Science, Data Warehouse


Job Description

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 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