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CSV Engineer

• Posted 7 hours ago • Updated 7 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

URS
DirectShow
DS
IQ
OQ
PQ
Management
Traceability Matrix
Collaboration
Automated Testing
Auditing
Computer Science
Life Sciences
Computerized System Validation
Pharmaceutics
GMP
GAMP
V-Model
Programmable Logic Controller
HMI
Regulatory Compliance
Data Integrity
Documentation
Communication
Stakeholder Management

Summary

Job Summary:

The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant with regulatory standards, including 21 CFR Part 11. The role requires strong expertise in GAMP 5 methodology, validation lifecycle processes, and experience with automation and control systems. This is an onsite position based in Bloomfield, Indiana.

Roles & Responsibilities:

Execute and manage computer system validation (CSV) activities in compliance with GAMP 5 and GMP regulations
Develop and review validation documentation including Validation Plans, URS (User Requirement Specifications), FS (Functional Specifications), DS (Design Specifications), and protocols (IQ/OQ/PQ)
Perform and oversee execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Ensure compliance with 21 CFR Part 11 requirements, including electronic records, audit trails, and data integrity
Work with automation and control systems such as DeltaV, PI Historian, Rockwell PLC, HMI, or similar platforms
Apply risk-based validation approaches and V-model lifecycle principles
Maintain and manage validation documentation such as RTMs (Requirement Traceability Matrices), validation summary reports, and SOPs
Collaborate with cross-functional teams including Automation, Quality Assurance, and IT
Support internal and external audits by providing validation documentation and compliance evidence

Education & Experience:

Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field
Minimum of 7+ years of experience in Computer System Validation within a pharmaceutical or GMP-regulated environment
Strong knowledge of GAMP 5 methodology, V-model lifecycle, and risk-based validation approaches
Hands-on experience with automation and control systems (e.g., DeltaV, PI Historian, Rockwell PLC, HMI)
Proven experience supporting 21 CFR Part 11 compliance and data integrity requirements
Excellent documentation, communication, and stakeholder management skills

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: ff7a83a73e1e5dd23aeefb7ed4c3c91e
Posted 7 hours ago

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