IT Validation Engineer – Lab Instrument Systems

HCLTech; Lakewood Township (NJ); On-site; USD 95,000 - 151,000; Full time

Job summary

HCLTech is seeking an IT professional to support system owners in generating and managing IT documentation for instrument qualification and computerized system validation in Baxter R&D environments.

Responsibilities include supporting laboratory IT systems, applying cGxP requirements, leading cross-functional projects, and handling qualification activities with proper documentation and change control processes.

Qualifications

• Solid understanding of IT functions related to instrument qualification.
• Experience or knowledge of pharmaceutical/biotech environments.
• Strong written and verbal communication skills.
• Strong organizational skills and ability to work independently or in teams.

Responsibilities

• Support IT activities for laboratory systems (AAS, GC, LC, MS, SEM, NMR, etc.).
• Learn and apply cGxP and SOP requirements and project procedures.
• Serve as IT project lead for intermediate scope projects with cross-functional teams.
• Assist with qualification of equipment and change controls; coordinate re-qualifications and retirements.
• Manage software/hardware documentation and archival for approved packages.

Skills

IT validation

Documentation

Communication (verbal/written)

Independent / team work

Education

BS degree in technical field

Tools

OpenLab ECM

Xybion Compliance Builder

ServiceNow

Job description

HCLTech is seeking an IT professional to support system owners in generating and managing IT documentation for instrument qualification and computerized system validation in Baxter R&D environments.

Responsibilities include supporting laboratory IT systems, applying cGxP requirements, leading cross-functional projects, and handling qualification activities with proper documentation and change control processes.