Computer System Validation Engineer

Creative Solutions Services, LLC; Princeton (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC seeks a qualified validation professional to ensure systems meet cGMP, data integrity, and regulatory requirements through a risk-based approach. You will support lifecycle management, testing strategies, and cross-functional collaboration to drive operational efficiency.

The role emphasizes developing validation documentation, conducting testing, and coordinating with QA and IT to enhance data governance and visualization capabilities.

Qualifications

• 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 listed analytical tools and Excel spreadsheet validation.
• Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.

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 QA and other teams to optimize 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.

Skills

Validation

IT quality assurance

Data governance

Data visualization

Cross-functional teamwork

Education

Bachelor's degree in CS/Engineering/Bio Sci

Tools

UPLC

HPLC

HIAC

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.