GxP System Engineer

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.