GxP Systems Engineer: Hamilton Instrumentation & CSV Expert

Katalyst CRO; Norwood (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO seeks an experienced GxP System Engineer in Norwood, MA, to support validation, compliance, and lifecycle management for critical laboratory systems, with emphasis on Hamilton instrumentation and CSV within a regulated pharmaceutical environment.

You will lead IQ/OQ/PQ activities, ensure FDA/GxP adherence, manage validation docs (URS, FRS, SOPs), and collaborate with QA, IT, and operations to sustain data integrity and inspection readiness.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, Computer Science, Pharmacy or related technical discipline preferred.
• 6–12+ years of experience in pharmaceutical, biotechnology, or regulated laboratory environments.
• Relevant experience in Hamilton Instrumentation, CSV, and GxP system validation required.

Responsibilities

• Support validation and compliance activities for Hamilton Instrumentation and laboratory automation systems in a GxP-regulated environment.
• Perform Computer System Validation (CSV) activities including validation planning, risk assessments, protocol execution, and final reporting.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for laboratory systems and instruments.
• Ensure compliance with FDA regulations, GxP guidelines, data integrity principles, and internal quality procedures.
• Prepare, review, and maintain validation documentation including URS, FRS, SOPs, validation plans, test scripts, traceability matrices, and validation reports.
• Support audit readiness activities by maintaining accurate, compliant, and inspection-ready documentation.
• Collaborate with Quality Assurance, Laboratory Operations, Engineering, IT, and Validation teams to support system implementation and lifecycle management.
• Troubleshoot system issues, support deviation investigations, and assist with CAPA activities.
• Support change control, system upgrades, periodic reviews, and compliance assessments for laboratory systems.
• Ensure high availability and operational reliability of critical pharma laboratory systems.

Skills

Hamilton Instrumentation

Laboratory automation

Computer System Validation

IQ/OQ/PQ validation

FDA regulations & GxP

Documentation & audit readiness

Education

Bachelor’s degree in engineering / Life Sciences / CS / Pharmacy

Tools

URS

FRS

SOPs

Job description

Katalyst CRO seeks an experienced GxP System Engineer in Norwood, MA, to support validation, compliance, and lifecycle management for critical laboratory systems, with emphasis on Hamilton instrumentation and CSV within a regulated pharmaceutical environment.

You will lead IQ/OQ/PQ activities, ensure FDA/GxP adherence, manage validation docs (URS, FRS, SOPs), and collaborate with QA, IT, and operations to sustain data integrity and inspection readiness.