GxP System Engineer
Job in
Norwood, Norfolk County, Massachusetts, 02062, USA
Listed on 2026-06-18
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-06-18
Job specializations:
-
Quality Assurance - QA/QC
-
Engineering
Job Description & How to Apply Below
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.
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.
- 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.
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