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# GxP System Engineer

- **Company:** Katalyst Talent Agency
- **Location:** Norwood, MA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Data Integrity, Network Troubleshooting, System Testing, Iq/oq/pq, System Availability, Test Scripts, Information Technology, GXP
- **Published:** May 15, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=14f5db55d665ed6e

## About the Role

Do you have experience in Pharmaceutical regulatory compliance?, * 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.

## 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.

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.


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