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Job Details

Skills

Computerized System Validation
Lifecycle Management
Operational Efficiency
Good Manufacturing Practice
Computer Hardware
Training
Testing
Risk Assessment
Change Management
Backup
Configuration Management
Documentation
Acceptance Testing
Traceability Matrix
Collaboration
Communication
Quality Assurance
Quality Control
Pharmaceutical Industry
Regulatory Compliance
Data Integrity
Cross-functional Team
Data Governance
HPLC
TOC
Theory Of Constraints
Microsoft Excel
Computer Science
Science

Computerized System Validation
Lifecycle Management
Operational Efficiency
Good Manufacturing Practice
Computer Hardware
Training
Testing
Risk Assessment
Change Management
Backup
Configuration Management
Documentation
Acceptance Testing
Traceability Matrix
Collaboration
Communication
Quality Assurance
Quality Control
Pharmaceutical Industry
Regulatory Compliance
Data Integrity
Cross-functional Team
Data Governance
HPLC
TOC
Theory Of Constraints
Microsoft Excel
Computer Science
Science

Summary

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:

pply 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.
nalyze 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.
bility 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.

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: 5b957a5f65dcf7d055e026a76c001bdc
Posted 1 day ago

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Computer System Validation Engineer

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