Computer System Validation Engineer

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

Computer System Validation Engineer - Contract - Princeton, NJ

Keep the heartbeat of innovation running! Join our client in this engineering position and ensure cutting‑edge validation engineering never misses a beat!

Proclinical is seeking a Computer System Validation Engineer to support the validation and compliance of GxP computer systems.

Primary Responsibilities

In this role, you will collaborate with cross‑functional teams to ensure systems meet quality standards and regulatory requirements through a risk‑based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.

Key Responsibilities

• Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
• Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.
• Facilitate risk assessments to identify validation deliverables and project requirements.
• Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.
• Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
• Analyze validation data and troubleshoot issues in collaboration with technical teams.
• Maintain communication with stakeholders to address system needs, validation progress, and related concerns.

Qualifications and Experience

• Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
• Hands‑on experience in validating computerized systems.
• Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
• Ability to work effectively in a dynamic, cross‑functional team environment.
• Proven expertise in applying data governance measures and creating impactful data visualizations.
• Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.
• Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.

Compensation

• $48 to $60 per hour.