GxP Validation Engineer: Data Integrity & Compliance

Proclinical Group; Princeton (NJ); On-site; USD 66,124 - 82,656; Full time

Job summary

Proclinical Group seeks a Computer System Validation Engineer to support validation and compliance of GxP computer systems in Princeton, NJ on a contract basis. You will validate hardware, software, procedures, and training to ensure systems meet quality and regulatory requirements.

You will apply data integrity principles, perform risk assessments, and develop validation documentation while collaborating with QA and IT to optimize change control and lifecycle management.

Qualifications

• Experience validating computerized systems in pharma or biotech.
• Knowledge of US/EU data integrity guidance.
• Experience with risk-based validation approaches.
• Ability to collaborate across QA, IT, and operations.

Responsibilities

• Validate computer systems including hardware, software, procedures, and training.
• Apply cGMP and Data Integrity principles in validation testing.
• Perform risk assessments to identify deliverables.
• Develop validation documentation and reports.
• Collaborate with QA and IT to optimize processes.
• Maintain communication with stakeholders on progress.

Skills

Validation engineering

Data integrity

Regulatory compliance

Cross-functional teamwork

Data visualization

Problem solving

Education

Bachelor's degree in Computer Science/Engineering/Biological Sciences

Tools

UPLC

HPLC

HIAC

qPCR

NanoDrop

TOC Analyzer

Osmometer

Cell Counters

Excel

Job description

Proclinical Group seeks a Computer System Validation Engineer to support validation and compliance of GxP computer systems in Princeton, NJ on a contract basis. You will validate hardware, software, procedures, and training to ensure systems meet quality and regulatory requirements.

You will apply data integrity principles, perform risk assessments, and develop validation documentation while collaborating with QA and IT to optimize change control and lifecycle management.