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Internship Computer System Validation Csv Jobs in Pennsylvania

Pharmaron

Software Validation Senior Associate

Exton, PA · On-site

$75K - $85K/yr

Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline (or equivalent experience). * Minimum of 3 years of Computerized Systems Validation (CSV ...

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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.

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

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Internship Computer System Validation Csv jobs near you
Infographic showing various Internship Computer System Validation Csv job openings in Pennsylvania as of August 2026, with employment types broken down into 78% Full Time, and 22% Contract. Highlights an 100% In-person job distribution.

Computer System Validation (CSV) Engineer

Hired by Matrix

Myerstown, PA • On-site

$65/hr

Contractor

Medical, Dental

Posted 7 days ago

Job description

At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Computer System Validation (CSV) Engineer.

Position Type:

  • Contract
  • Onsite

Required:

  • Bachelor's in Life Sciences, Engineering, or Computer Science
  • 7 years of CSV experience in a regulated pharma or life sciences environment
  • Hands-on validation experience with LIMS, ERP, or MES systems
  • Strong knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11
  • Ability to author complete, inspection-ready validation packages independently
  • Experience conducting and documenting formal risk assessments

Preferences:

  • Experience validating cloud-based or SaaS systems under GAMP 5 Category 4/5
  • Familiarity with Veeva Vault, Kneat, or similar electronic validation platforms
  • Prior experience supporting FDA or EMA inspections in a CSV capacity
  • Background in biologics, clinical manufacturing, or combination products

Responsibilities:

  • Own the validation lifecycle for GxP-regulated computer systems
  • Work directly with quality, IT, and manufacturing teams to deliver compliant, audit-ready validation packages
  • Lead end-to-end validation of LIMS, ERP, and MES systems per 21 CFR Part 11 and GxP regulations
  • Author, execute, and review URS, FS, Validation Plans, IQ/OQ/PQ protocols, and Summary Reports
  • Manage periodic reviews and revalidation of existing validated systems
  • Coordinate with system owners, vendors, and IT to define scope, timelines, and deliverables
  • Apply GAMP 5 principles to classify systems and define risk-based validation strategies
  • Conduct formal risk assessments including FMEA and maintain site-level risk registers
  • Ensure risk controls are reflected in validation test scripts and traceability matrices
  • Assess computerized systems for data integrity compliance including audit trails, access controls, and electronic records
  • Evaluate and remediate 21 CFR Part 11 gaps in existing validated systems
  • Support data integrity investigations and respond to related audit findings
  • Serve as CSV SME during FDA, EMA, and client audits and inspections
  • Author and maintain SOPs, deviations, change controls, and CAPAs for validated systems
  • Stay current with 21 CFR Part 11, EU Annex 11, ICH Q9, and USP 1058 guidance