Impactful Computer System Validation Engineer

Creative Solutions Services, LLC

Princeton (NJ)

On-site

USD 90,000 - 130,000

Full time

14 days+

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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.