Computer System Validation Engineer

Denver, CO, US • Posted 11 hours ago • Updated 31 minutes ago

Full Time

Part Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Lifecycle Management
Bridging
Operational Excellence
GxP
URS
DS
DirectShow
IQ
OQ
PQ
Traceability Matrix
Environmental Management
Element Management System
EMS
Regulatory Compliance
Asset Management
Change Control
Cellular
Collaboration
Quality Assurance
Computer Science
Computerized System Validation
Pharmaceutics
GMP
GAMP
Computer Hardware
MES
Data Integration
OPC
Scheduling
Documentation
Risk Assessment
Communication
Manufacturing
Data Integrity
Auditing
SANS
Management

Summary

We are looking for an experienced CSV Engineer to support the validation and lifecycle management of computerized systems in GMP-regulated manufacturing environments. The role bridges automation, IT, and quality compliance, ensuring validated systems maintain data integrity, regulatory compliance, and operational excellence.

Key Responsibilities

Lead and execute Computer System Validation (CSV) activities in line with GxP, FDA, and EU GMP requirements
Develop, review, and manage validation documentation, including URS, FS, DS, IQ/OQ/PQ protocols, risk assessments, and traceability matrices
Support commissioning and qualification of Building Management Systems (BMS) and Environmental Management Systems (EMS)
Validate and maintain DeltaV hardware, applications, and software environments
Oversee MES validation for Production and Quality modules
Integrate and validate industrial data platforms such as HighByte and Kepware
Support automation and scheduling platforms (Dynamic Equipment Scheduler, Green Button Go)
Ensure validated state compliance for asset management and change control platforms (OctoPlant)
Contribute to validation for advanced manufacturing systems like Cellular Origins Constellation
Collaborate cross-functionally with QA, IT, Engineering, and Operations teams

Required Qualifications

Bachelor s degree in Engineering, Computer Science, or related field
Proven CSV experience in pharmaceutical, biotech, or advanced manufacturing environments
Strong knowledge of GMP, GAMP 5, 21 CFR Part 11, and EU Annex 11
Hands-on experience with DeltaV systems (hardware, application, software)
Experience validating MES Production and Quality modules
Familiarity with industrial data integration, OPC connectivity, and automation scheduling tools
Excellent documentation, risk assessment, and stakeholder communication skills

Preferred Qualifications

Experience in cell therapy or highly automated manufacturing environments
Strong understanding of data integrity principles and audit readiness
Ability to manage multiple validation projects simultaneously

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: 90737436
Position Id: OOJ - 8084-7088-1773322745
Posted 11 hours ago

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