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GxP System Engineer

Norwood, MA, US • Posted 2 days ago • Updated 5 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Risk Assessment
Reporting
IQ
OQ
PQ
Data Integrity
URS
FRS
Test Scripts
Traceability Matrix
Auditing
Inspection
Documentation
Collaboration
Quality Assurance
System Implementation
Lifecycle Management
Corrective And Preventive Action
Change Control
Regulatory Compliance
High Availability
Life Sciences
Computer Science
Pharmacy
Pharmaceutics
Biotechnology
Instrumentation
Computerized System Validation
GxP

Summary

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 16e7e224d30dd31b1280297320befc08
Posted 2 days ago

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