Computer System Validation Engineer

Princeton, NJ, US • Posted 60+ days ago • Updated 7 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

IQ
OQ
PQ
System Requirements
Risk Assessment
URS
Systems Design
Change Control
Management
Regulatory Compliance
Computer Science
Life Sciences
Computerized System Validation
GxP
GAMP
Documentation
Analytical Skill
Conflict Resolution
Problem Solving
Communication
Collaboration
Teamwork
Enterprise Resource Planning
LIMS
MES
Project Management
Auditing
Data Integrity
Quality Assurance
Medical Devices
Biotechnology
Pharmaceutical Industry

Summary

Job Description
Summary:
The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality Assurance, and business stakeholders to validate new and existing systems, document validation evidence, and support audits and inspections.
Roles & responsibility:

Knowledge on FDA Guidance's and industry Standards
Develop and execute validation plans, protocols (IQ/OQ/PQ), and reports for computer systems.
Assess and document system requirements, risk assessments, and user requirements specifications (URS).
Review and approve system design, configuration, and test documentation.
Ensure compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11).
Manage change control and deviation management processes for validated systems.
Collaborate with cross-functional teams (IT, QA, business users) to ensure validation deliverables are met.
Maintain validation documentation and support periodic reviews and revalidation.
Participate in internal and external audits and respond to regulatory inquiries.
Train users and stakeholders on validated systems and compliance requirements.
Stay current with industry trends, regulations, and best practices in computer system validation.

Education & Experience:

Bachelor's degree in Computer Science, Life Sciences, Engineering, or related field.
2+ years of experience in computer system validation or a regulated industry.
Knowledge of applicable regulations (FDA, EMA, GxP, 21 CFR Part 11, Annex 11).
Experience with validation methodologies (GAMP 5, risk-based validation).
Strong documentation, analytical, and problem-solving skills.
Excellent communication and teamwork abilities.
Experience with ERP, LIMS, MES, or other regulated systems is a plus
Familiarity with project management tools and methodologies
Experience with audit preparation and participation.
Understanding of data integrity principles.
Certification in validation or quality assurance (e.g., ASQ, ISPE) is a plus.
Prior work experience in Medical Device Industry, Biotechnology or Pharmaceutical industry is a plus.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: a85042aa44aceb1bd7ef2fc218fdc6f9
Posted 30+ days ago

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