GxP System Engineer

GxP System Engineer – Hamilton System (Instrumentation)

Location: Norwood, MA, USA (Onsite Only)
Client: Infosys
Role: GxP System Engineer – Hamilton Systems (Instrumentation)

Job Description

We are looking for 2 strong GxP System Engineers with hands-on experience in Hamilton Systems and instrumentation support within a regulated pharmaceutical environment. The ideal candidate will ensure system compliance, validation, and reliable operation of GxP-controlled systems.

Key Responsibilities

• Support and maintain Hamilton instrumentation systems in a GxP-regulated environment
• Perform system configuration, validation, and qualification activities (IQ/OQ/PQ)
• Ensure compliance with FDA, GxP, and pharmaceutical regulatory standards
• Troubleshoot system and instrumentation issues in production/lab environments
• Work closely with QA, validation, and engineering teams
• Maintain documentation for system changes, validations, and audits
• Support system upgrades, patches, and lifecycle management
• Ensure data integrity and system reliability across operations

Required Skills

• 6–10 years (Junior/Intermediate) or 11+ years (Senior level experience)
• Strong experience with Hamilton Systems / Laboratory Instrumentation
• Experience in GxP regulated pharmaceutical environment
• Knowledge of system validation (CSV – Computer System Validation)
• Strong understanding of FDA compliance and audit requirements
• Experience in documentation and validation protocols
• Strong troubleshooting and analytical skills

Preferred Skills

• Experience with pharma manufacturing or biotech environments
• Familiarity with lab automation systems
• Experience working with cross-functional QA and engineering teams