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 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

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