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Computer System Validation Manager Jobs in Colorado

Stefanini Group

IT Specialist II

Aurora, CO · On-site

$35 - $40/hr

... Management, Open+, Logistic supply chain) * Actively participate in the implementation of new ... Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience ...

Stefanini Group

IT Specialist II

Aurora, CO

... Management, Open+, Logistic supply chain) * Actively participate in the implementation of new ... Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience ...

SAIC

Senior SVAT System Administrator

Colorado Springs, CO · On-site

$84K - $114K/yr

... Validation and Testing (SVAT) Lead in Colorado Springs, COto manage and govern IT service ... Bachelor's degree in Computer Science, Information Technology, System Engineering, or a related ...

SAIC

Senior SVAT System Administrator

Colorado Springs, CO · On-site

$84K - $114K/yr

... Validation and Testing (SVAT) Lead in Colorado Springs, CO to manage and govern IT service ... Bachelor's degree in Computer Science, Information Technology, System Engineering, or a related ...

SAIC

Senior SVAT System Administrator

Colorado Springs, CO

$84K - $114K/yr

... Validation and Testing (SVAT) Lead in Colorado Springs, CO to manage and govern IT service ... Bachelor's degree in Computer Science, Information Technology, System Engineering, or a related ...

Stefanini

IT Specialist II

Aurora, CO · On-site

... Computer System Validation (CSV) Hands-on experience supporting MES/LES platforms in production ... management and validation procedures Support system upgrades, patches, and enhancements in ...

Watchmaker Genomics

IT Systems Engineer

Boulder, CO · On-site

Develop and use automation tools/scripts to streamline operations and system management. * Computer Systems Validation: Perform required Computer Systems Validation actions. * Documentation and ...

Watchmaker Genomics

IT Systems Engineer

Boulder, CO

Develop and use automation tools/scripts to streamline operations and system management. * Computer Systems Validation: Perform required Computer Systems Validation actions. * Documentation and ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Colorado

Computer System Validation Manager information

See Colorado salary details

$49.9K

$110.8K

$168.8K

How much do computer system validation manager jobs pay per year?

As of Aug 10, 2026, the average yearly pay for computer system validation manager in Colorado is $110,846.00, according to ZipRecruiter salary data. Most workers in this role earn between $78,300.00 and $138,800.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a computer system validation manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are popular job titles related to Computer System Validation Manager jobs in Colorado? For Computer System Validation Manager jobs in Colorado, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Colorado look for? The top searched job categories for Computer System Validation Manager jobs in Colorado are:
What cities in Colorado are hiring for Computer System Validation Manager jobs? Cities in Colorado with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you

IT Specialist II

Stefanini Group

Aurora, CO • On-site

$35 - $40/hr

Full-time

Posted 7 days ago

Job description

Details:
Stefanini Group is looking for a IT Specialist II for a globally recognized company! For interested applicants, click the apply button or you may reach out Micah Andres at (248) 386-7399/Micah.Andres@Stefanini.com for faster processing. Thank you!
We're seeking an IT Operations Analyst Candidate with a strong technical foundation and extensive experience supporting complex manufacturing and laboratory IT environments. This role requires a seasoned professional who can independently lead system deployments, troubleshoot critical production issues, and act as a trusted technical partner to Operations, Quality, and Engineering teams.
Job Responsibilities:
  • Understand the business requirements; perform analysis and translation of business requirements to technical specifications; provide solutions design, build, and deploy IT solutions and services; provide maintenance and support.
  • Act as IT service and solution facilitator for IT factory-based systems (Manufacturing, Quality, Warehouse Management, Open+, Logistic supply chain)
  • Actively participate in the implementation of new systems and digital initiatives in the Manufacturing and Supply Chain areas.
  • Collect business requirements for changes in processes and technical areas.
  • Formalize scope and deliverables for technical processes and changes.
  • Execute the deployment and localization of the global IT system solutions.
  • Execute Digital Pillar activities (Align with Operations zero loss journey and boot performance by digital capabilities).
  • Provide maintenance and support for local and global IT system solutions. Perform troubleshooting and solving issues as they occur in day-to-day business.
  • Adhere to relevant policies, procedures, and standards to achieve quality and compliance of solutions and services.
  • Collaborate with equipment vendors and internal stakeholders to qualify laboratory instruments and systems in accordance with GxP guidelines.
  • Prepare, review, and maintain Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for IT systems.
  • Track and document configuration changes to lab equipment and associated software to ensure traceability and compliance.
  • Coordinate and execute IT resiliency and disaster recovery procedures specific to IT systems, ensuring business continuity and data integrity.
  • Support periodic validation and requalification of Lab IT systems to maintain compliance with GxP and regulatory standards.
  • Act as primary IT liaison for lab-based systems, ensuring integration with global IT platforms while meeting local compliance and operational needs.
  • Monitor and respond to lab IT incidents, ensuring timely resolution and proper escalation where required.

Job Requirements
Details:
Skills, Licenses, Knowledge, Education and Training Requirements:
  • Bachelor's degree in computer science, Information Systems, Engineering, or a related technical field (or equivalent experience)
  • 7+ years of progressive experience in IT operations, application support, or solution delivery within manufacturing or regulated industrial environments
  • Experience working in multinational/global organizations supporting site-level deployment of global systems
  • Strong background in GMP, GAMP, and Computer System Validation (CSV)
  • Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments
  • Strong SAP experience (ECC and/or S/4HANA) supporting manufacturing, supply chain, or quality processes
  • Deep understanding of manufacturing execution, materials management, and supply chain workflows
  • Provide operational support for mission-critical production and lab systems.
  • Support incident triage, root cause analysis, and corrective actions to minimize production impact
  • Execute validation activities in accordance with established CSV and GxP frameworks
  • Implement approved system changes following established change management and validation procedures
  • Support system upgrades, patches, and enhancements in coordination with global IT teams

Level of Knowledge, Skills, and Authority:
  • Advanced troubleshooting across applications, database, and interface layers
  • Strong SQL skills for data analysis, incident investigation, and validation support
  • Experience with system integrations, data flows, and change control in validated environments
  • Experience with IT resiliency, disaster recovery, and business continuity for mission-critical systems
  • Write and execute SQL statements to support operational reporting, incident investigation, data validation, and root cause analysis; troubleshoot SQL query performance, data integrity, and interface-related data issues.
  • Provide hands-on support for Operational Technology (OT) systems in manufacturing and laboratory environments, including MES/LES, equipment interfaces, historian systems, and shop floor applications.
  • Understand IT/OT system platform architecture, including application, database, interface, middleware, and infrastructure layers, and how they interact within regulated manufacturing environments.
  • Troubleshoot issues across the IT/OT boundary, identifying root causes related to applications, databases, interfaces, or network connectivity, and supporting OT teams during production-impacting events.
  • Support OT and manufacturing teams with real-time troubleshooting of system behavior, data flow disruptions, and integration issues affecting production and quality processes.
  • Demonstrate working knowledge of network and connectivity concepts, including firewall rules, ports and protocols, and network segmentation between IT and OT zones.
  • Collaborate with network and infrastructure teams to diagnose and resolve connectivity issues impacting manufacturing, laboratory, and OT systems while adhering to site security and compliance standards.

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Pay Range:
$ 35.00 - $ 40.00

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