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Internship 21 Cfr Part 11 Validation Jobs (NOW HIRING)

Inteldot

WI · On-site

$110 - $140/hr

The ideal candidate will have extensive experience validating computerized systems within the ... Ensure compliance with FDA, cGMP, GAMP 5, ALCOA+, and 21 CFR Part 11 requirements. * Collaborate ...

Apex Informatics

Validation Tester

Farmingdale, NY · On-site

... 21 CFR Part 11 compliance validation and Computer Systems Validation (CSV) • Deep understanding of FDA regulations, GxP requirements, and data integrity • Experience supporting FDA approval ...

HPTech Inc.

Validation Lead

Raritan, NJ · On-site

Role - Validation Lead Location - Raritan, NJ (Hybrid) W2/C2C Job Details: 5+ years of Computer ... 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical ...

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CSV Engineer

Katalyst Healthcares and Lifesciences

Woburn, MA • On-site

Other

Posted 4 days ago

Job description

Job Summary:
  • We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment.
  • The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance.

Roles & Responsibilities:
  • Develop, execute, and maintain Computer System Validation (CSV) documentation and validation protocols for QC laboratory systems and manufacturing systems.
  • Support the complete validation lifecycle, including preparation, execution, review, and approval of User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Risk Assessments, and Validation Reports.
  • Perform risk assessments to identify and mitigate validation and compliance risks.
  • Ensure compliance with GAMP 5, 21 CFR Part 11, GMP, and internal quality standards.
  • Review validation documentation to ensure accuracy, completeness, and regulatory compliance.
  • Collaborate with Quality Assurance (QA), Manufacturing, Engineering, and IT teams to support validation activities and system implementations.
  • Provide validation support for QC laboratory systems and manufacturing equipment throughout their lifecycle.
  • Assist with change control, deviation investigations, and periodic reviews related to validated systems.
  • Maintain accurate validation records and ensure documentation is audit ready.
  • Support internal and external regulatory inspections by providing validation documentation and technical expertise.

Requirements / Qualifications:
  • Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or a related field.
  • Experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment.
  • Strong knowledge of GAMP 5, 21 CFR Part 11, and GMP regulations.
  • Hands-on experience supporting QC laboratory systems and/or manufacturing equipment validation.
  • Experience developing and reviewing validation lifecycle documentation, including URS, IQ, OQ, PQ, Risk Assessments, and Validation Reports.
  • Experience working collaboratively with Quality Assurance (QA), Manufacturing, Engineering, and IT teams.
  • Strong understanding of the CSV lifecycle, risk-based validation, and documentation best practices.
  • Excellent technical writing, documentation, communication, and problem-solving skills.
  • Ability to manage multiple validation activities while maintaining compliance with regulatory and quality requirements.

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