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Internship Computer System Validation Csv Jobs in New York

ClinDCast, LLC

CSV Consultant

Raritan, NJ · On-site

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV) , SAP ERP , and Generative AI/Agentic AI in a GxP-regulated environment . The ideal candidate will have ...

ClinDCast LLC

CSV Consultant

Raritan, NJ · On-site

$45 - $50/hr

Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications. * Develop and execute validation documentation, including Validation Plans, Requirements, Test ...

Katalyst CRO

CSV Engineer

Somerset, NJ · On-site

Required : • Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline • 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences ...

Katalyst CRO

CSV Engineer

Somerset, NJ · On-site

Required : • Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline • 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences ...

CYNET SYSTEMS

Validation Lead

Raritan, NJ · On-site

$50 - $55/hr

Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and separation contexts. * Experience in writing and executing documentation for all aspects of ...

CYNET SYSTEMS

CSV Consultant

Raritan, NJ · On-site

$48 - $53/hr

Pay Range: $48hr - $53hr Requirement/Must Have: * 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and ...

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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 New York?

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

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For Internship Computer System Validation Csv jobs in New York, the most frequently searched job titles are:

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Internship Computer System Validation Csv jobs near you
Infographic showing various Internship Computer System Validation Csv job openings in New York as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution.

Computer System Validation (CSV) Engineer

Spadtek Solutions LLC

Piscataway, NJ • On-site

Other

Posted 4 days ago

Job description

Title : Computer System Validation (CSV) Engineer
Locations: Piscataway, NJ  | Chicago, IL 
Work Arrangement: Onsite
Employment Type: Full-Time
Experience: 5+ Years of CSV Experience in a GxP-Regulated Environment

Job Summary

We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, manufacturing and engineering equipment, and enterprise applications.

The CSV Engineer will work closely with Quality, IT, Laboratory, and Manufacturing teams to ensure computerized systems remain validated and compliant with GxP, 21 CFR Part 11, EU Annex 11, and applicable EMA requirements.

This is an onsite position reporting to the Sr. Director of IT. The successful candidate will have strong hands-on experience developing and executing CSV deliverables within a regulated life sciences environment.

Key Responsibilities
  • Plan, author, review, and execute CSV deliverables, including:
    • Validation Plans
    • User Requirements Specifications (URS)
    • Functional Specifications (FS)
    • Design Specifications (DS)
    • IQ/OQ/PQ protocols
    • Traceability Matrices
    • Validation Summary Reports (VSR)
  • Perform CSV activities for:
    • Laboratory instruments such as HPLC, spectrophotometers, and balances
    • Engineering and manufacturing equipment
    • LIMS platforms
    • SAP systems
    • CMMS/calibration systems such as BMRAM
  • Partner with System Owners, QA, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state.
  • Support change control, periodic reviews, and validation lifecycle activities.
  • Conduct computerized system risk assessments and data integrity assessments in alignment with ALCOA+ principles.
  • Support audits, regulatory inspections, CAPA investigations, deviations, and compliance activities related to computerized systems.
  • Collaborate with senior validation leads and subject matter experts to establish and maintain consistent CSV practices across sites.
  • Ensure validation documentation meets applicable regulatory and quality standards.
Required Qualifications
  • Bachelor's degree in Life Sciences, Engineering, Information Technology, or a related field, or equivalent laboratory experience within a life sciences environment.
  • Minimum 5 years of Computer System Validation (CSV) experience in a GxP-regulated environment.
  • Strong working knowledge of:
    • 21 CFR Part 11
    • EU Annex 11
    • EMA guidance
    • GxP compliance requirements
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols.
Preferred Qualifications
  • Familiarity with GAMP 5 principles.
  • Experience with risk-based validation methodologies.
  • Exposure to Caliber LIMS.
  • Experience with SAP QM, MM, or PP in a GxP environment.
  • Experience with BMRAM or comparable CMMS/calibration systems.
  • Experience working as a liaison between IT, Quality, Laboratory, and Manufacturing teams.
  • Strong understanding of computerized system lifecycle management and data integrity principles.

Apply