GxP System Engineer

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

• We are seeking an experienced GxP System Engineer with strong expertise in Hamilton Instrumentation, laboratory automation systems, and Computer System Validation (CSV) within a regulated pharmaceutical environment. The ideal candidate will support validation, compliance, qualification, and operational activities for critical laboratory systems while ensuring adherence to FDA regulations, GxP guidelines, and data integrity standards.
• The candidate should possess hands-on experience with Hamilton Liquid Handling systems, IQ/OQ/PQ validation activities, audit readiness, and regulated documentation practices supporting pharmaceutical and laboratory operations.
• 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 and support 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.

Job Summary

• We are seeking an experienced GxP System Engineer with strong expertise in Hamilton Instrumentation, laboratory automation systems, and Computer System Validation (CSV) within a regulated pharmaceutical environment. The ideal candidate will support validation, compliance, qualification, and operational activities for critical laboratory systems while ensuring adherence to FDA regulations, GxP guidelines, and data integrity standards.
• The candidate should possess hands-on experience with Hamilton Liquid Handling systems, IQ/OQ/PQ validation activities, audit readiness, and regulated documentation practices supporting pharmaceutical and laboratory operations.

Roles & 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 and support 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.

Education & Experience

• 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.
• Equivalent combination of education and industry experience will also be considered.