GxP Instrument Systems Engineer / Senior Project Engineer at AHU Technologies INC.

About Us

AHU Technologies INC. is an IT consulting and permanent staffing firm dedicated to meeting and exceeding the evolving IT service needs of leading corporations across the United States. We provide comprehensive IT solutions to clients in various industries, enabling them to manage costs and focus internal resources on strategic objectives. Founded by visionary techno-commercial entrepreneurs, AHU Technologies maintains strong relationships with skilled independent consultants, allowing us to offer a growing pool of resources for diverse development projects. Our current project portfolio spans media entertainment, ERP solutions, data warehousing, web applications, telecommunications, and medical sectors for clients worldwide.

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 integrate with connected Digital platforms.

Job Responsibilities

• Collaborate with Business Analysts and Software/Automation Engineers throughout the complete product lifecycle management of Digital Quality Automation Systems (e.g., Hamilton Venus, Waters Andrew+ with OneLab) and Enterprise Instrumentation Systems (e.g., Chromeleon Chromatography Data System, LogiLab SDMS/CFR Gateway, SoftMax Pro, MODA).
• Oversee optimizations, support, maintenance updates, and version upgrades for these systems.
• 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.) to ensure 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 project duration.
• Participate in internal and external audits as required.

Requirements

• Bachelor’s degree or equivalent in a science, engineering, or computer science discipline.
• 5 to 7+ years of experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) within a biopharmaceutical GMP environment.
• Direct experience with automation solutions such as Hamilton Venus.
• Experience working with advanced automated laboratory analytical systems like Waters Andrew+, Oxford Nanopore, and Hamilton Venus liquid handlers.
• Familiarity with GAMP and GxP compliance regulations.
• Experience with data integrity regulations, instrument integration, and laboratory digital workflow optimization.
• Experience with cloud-hosted Digital systems 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 as part of a team, with effective cross-functional communication skills.
• Capacity 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.

This is a remote position. (Note: While described as remote, the location details indicate a hybrid on-site requirement.)