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GxP System Engineer

Katalyst Healthcares & Life Sciences

Norwood, MA

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JOB DETAILS
SKILLS
Automation Systems, Biology, Biotech and Pharmaceutical, Change Control, Computer Science, Computer Systems, Corrective and Preventative Action (CAPA) Systems, Data Quality, Documentation, FDA Requirements, GxP, High Availability, Identify Issues, Information Technology & Information Systems, Instrumentation, Laboratory Analysis, Laboratory Automation, Laboratory Operations, Laboratory Systems, Maintain Compliance, Pharmacy, Process Validation, Quality Assurance, Regulatory Compliance, Risk Analysis, Standard Operating Procedures (SOP), Support Documentation, System Lifecycle, System Validation, Systems Administration/Management, Systems Analysis, Systems Engineering, Test Scripts, Traceability, Validation Documentation, Validation Plan
LOCATION
Norwood, MA
POSTED
24 days ago
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.

About the Company

K

Katalyst Healthcares & Life Sciences

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