remote
GxP Instrument Systems Engineer- Norwood, MA - AHU Technologies
Systems Engineer
Senior GxP Instrument Systems Engineer leading design, deployment, and integration of automated QC laboratory instrumentation and digital quality platforms using tools like Hamilton Venus, Waters Andrew+, Chromeleon, and Scientific Data Management systems.
About the role
Key Responsibilities
- Lead the end‑to‑end design and deployment of GxP‑compliant instrumentation for Quality Control laboratories.
- Collaborate with Business Analysts and Software/Automation Engineers to manage the full product lifecycle of Digital Quality Automation Systems such as Hamilton Venus and Waters Andrew+ with OneLab.
- Integrate Enterprise Instrumentation Systems (Chromeleon Chromatography Data System, Scientific Data Management) with connected digital platforms to ensure seamless data flow and regulatory compliance.
- Develop and maintain system specifications, validation plans, and documentation in accordance with GxP standards.
- Provide technical support and troubleshooting for instrument and software issues, ensuring minimal downtime and data integrity.
Requirements
- 5+ years of experience in instrumentation engineering within regulated environments (GxP, FDA, ISO).
- Proficiency with laboratory automation platforms (Hamilton Venus, Waters Andrew+, Chromeleon).
- Strong understanding of data management systems and digital quality platforms.
- Excellent problem‑solving skills and ability to work cross‑functionally.
- Effective communication skills for documentation and stakeholder interaction.
Skills
software developmentsystem designproblem solving