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Internship Computer System Validation Csv Jobs in Colorado

Stefanini Group

IT Specialist II

Aurora, CO · On-site

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 ...

Stefanini

IT Specialist II

Aurora, CO · On-site

... and Computer System Validation (CSV)Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environmentsStrong SAP experience (ECC and/or S/4HANA) supporting ...

Stefanini Group

IT Specialist II

Aurora, CO · On-site

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 ...

Stefanini Group

IT Specialist II

Aurora, CO · On-site

$35 - $40/hr

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 ...

Stefanini Group

IT Specialist II

Aurora, CO · On-site

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 ...

Agilent

Validation Engineer

Boulder, CO · On-site

Generate, revise and execute validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 ...

Agilent

Validation Engineer

Frederick, CO · On-site

Generate, revise and execute validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 ...

Agilent

Validation Engineer

Frederick, CO · On-site

Generate, revise and execute validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 ...

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Internship Computer System Validation Csv information

What is an internship in computer system validation (CSV)?

An Internship in Computer System Validation (CSV) is a temporary position, typically for students or recent graduates, that provides hands-on experience in ensuring that computer systems used in regulated industries (like pharmaceuticals or healthcare) meet required standards and regulations. Interns assist with validating software and hardware, documenting processes, and ensuring compliance with industry guidelines such as FDA 21 CFR Part 11 or EU Annex 11. This role helps interns understand the lifecycle of computer systems in a regulated environment and prepares them for careers in quality assurance, compliance, or IT within highly regulated sectors.

What are the typical responsibilities of an intern in computer system validation (CSV)?

As a Computer System Validation (CSV) intern, you can expect to assist with tasks such as reviewing and drafting validation documentation, executing test scripts, and collecting evidence to ensure compliance with regulatory requirements. You may also support the maintenance of validation records and participate in team meetings to discuss project progress or findings. These responsibilities are crucial in ensuring that computer systems used in regulated industries, like pharmaceuticals or healthcare, function as intended and meet quality standards. Working closely with senior validation specialists, you'll gain hands-on experience with industry guidelines and learn how cross-functional teams collaborate to achieve compliance.

What are the key skills and qualifications needed for an internship in computer system validation (CSV)?

To thrive as an Internship Computer System Validation CSV specialist, you need foundational knowledge in computer science, life sciences, or engineering, along with an understanding of regulatory standards like GxP or FDA 21 CFR Part 11. Familiarity with validation documentation, software testing tools, and quality management systems is typically required. Attention to detail, analytical thinking, and effective communication are crucial soft skills for interpreting requirements and collaborating with cross-functional teams. These skills ensure compliance, data integrity, and the successful validation of computerized systems in regulated environments.

What is the difference between Internship Computer System Validation Csv vs Computer System Validation Specialist?

AspectInternship Computer System Validation CsvComputer System Validation Specialist
CredentialsTypically pursuing or recent graduate, basic understanding of validationRelevant certifications (e.g., GAMP, ISPE), experience preferred
Work EnvironmentInternship setting, supervised, entry-level tasksFull-time role, independent responsibilities in regulated industries
Industry UsageUsed in pharmaceutical, biotech, and medical device companies for trainingUsed for maintaining compliance, validating systems in regulated environments

In summary, the Internship Computer System Validation Csv is an entry-level position focused on learning and supporting validation tasks, while the Computer System Validation Specialist is a more experienced role responsible for ensuring system compliance and validation in regulated industries.

What are the most commonly searched types of Computer System Validation Csv jobs in Colorado?

The most popular types of Computer System Validation Csv jobs in Colorado are:

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Cities in Colorado with the most Internship Computer System Validation Csv job openings:

Internship Computer System Validation Csv jobs near you

IT Specialist II

Stefanini Group

Aurora, CO • On-site

Contractor

Posted 27 days ago

Job description

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.

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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Education:Bachelor (BA, BS...)Employment Type: CONTRACTOR

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