Computer System Validation Engineer

Katalyst-Healthcares-; Princeton (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a qualified professional to drive validation of computerized systems in a regulated setting. You will ensure data integrity, support lifecycle management, and collaborate across QA and technical teams.

Responsibilities include validating systems per cGMP, performing risk assessments, developing documentation, and delivering actionable data insights. Strong cross-functional collaboration and regulatory knowledge are essential.

Qualifications

• Experience in validation, IT quality assurance, biomanufacturing, clinical, or regulatory operations.
• Hands-on validation of computerized systems.
• Strong knowledge of US/EU data integrity guidance.
• Ability to work in a dynamic, cross-functional team.
• Data governance and impactful data visualizations expertise.

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 testing strategies.
• Facilitate risk assessments to identify validation deliverables and project requirements.
• Collaborate with QA and other teams to optimize change management, backups, configuration management, and reviews.
• Develop and execute validation documentation, including requirements, UAT, SOPs, impact assessments, traces, protocols, and reports.
• Analyze validation data and troubleshoot issues with technical teams.
• Maintain communication with stakeholders to address validation progress and needs.

Skills

Data governance

Data visualization

Risk assessment

Validation

Cross-functional teamwork

Regulatory compliance

Education

B.S. in CS/Eng/Biology

Tools

UPLC

HPLC

qPCR

NanoDrop

TOC Analyzer

Osmometer

Cell Counters

Excel

Job description

Job Description:

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.

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.

Requirements:

• 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.