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Temp 21 Cfr Part 11 Validation Jobs (NOW HIRING)

Hired by Matrix

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Computer System Validation (CSV) Engineer

Myerstown, PA · On-site

$65/hr

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 ...

New

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 ...

New

Arthur Lawrence

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Junior Validation Engineer - CSV/CQV

Cambridge, MA · On-site

$30 - $32/hr

Follow Good Manufacturing Practices (GMP) and 21 CFR Part 11 requirements. * Support the development and execution of Master Validation Plans, Standard Operating Procedures, and validation protocols ...

New

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 ...

Incorporan Inc

Validation Lead ( Need )

Raritan, NJ · On-site

Computer System Validation (CSV) experience in GxP -regulated environments, with hands-on ... 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical ...

New

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 ...

ClinDCast, LLC

CSV Consultant

Raritan, NJ · On-site

Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations. * Review and approve system testing, UAT scripts, design specifications, and validation deliverables. * Support ...

ClinDCast LLC

CSV Consultant

Somerville, NJ · On-site

$45 - $50/hr

Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations. * Review and approve system testing, UAT scripts, design specifications, and validation deliverables. * Support ...

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How much do temp 21 cfr part 11 validation jobs pay per hour?

As of Aug 13, 2026, the average hourly pay for temp 21 cfr part 11 validation in the United States is $50.45, according to ZipRecruiter salary data. Most workers in this role earn between $39.66 and $61.30 per hour, depending on experience, location, and employer.

What is the difference between Temp 21 Cfr Part 11 Validation vs Data Integrity Specialist?

AspectTemp 21 Cfr Part 11 ValidationData Integrity Specialist
CredentialsGxP validation experience, knowledge of 21 CFR Part 11GxP compliance, data integrity, auditing certifications
Work EnvironmentPharmaceutical, biotech labs, regulated environmentsQuality assurance, compliance departments in regulated industries
Industry UsageRegulatory validation of electronic systemsEnsuring data accuracy and compliance in data management

Temp 21 Cfr Part 11 Validation focuses on validating electronic systems to meet FDA regulations, ensuring systems are compliant with 21 CFR Part 11. Data Integrity Specialists concentrate on maintaining the accuracy, consistency, and reliability of data across systems, often working to ensure compliance with industry standards. While both roles require knowledge of GxP and compliance, validation emphasizes system testing and documentation, whereas data integrity emphasizes ongoing data quality and security.

What are the key skills and qualifications needed to thrive as a Temp 21 CFR Part 11 validation specialist, and why are they important?

To excel as a Temp 21 CFR Part 11 Validation Specialist, you need a solid understanding of FDA regulations, computer system validation (CSV), and quality assurance, usually supported by a degree in life sciences or engineering. Familiarity with validation protocols, GxP systems, and industry standards like ALCOA+, as well as experience with documentation and electronic record-keeping tools, is essential. Strong attention to detail, problem-solving abilities, and effective communication skills distinguish top performers in this role. These competencies are crucial to ensure regulatory compliance, data integrity, and the smooth operation of validated systems in pharmaceutical or biotech environments.

What is a Temp 21 CFR Part 11 validation specialist?

A Temp 21 CFR Part 11 Validation specialist is a temporary professional who ensures that electronic records and signatures in regulated industries, such as pharmaceuticals and biotechnology, comply with the requirements of 21 CFR Part 11. This regulation, set by the FDA, outlines the criteria for trustworthy and reliable electronic records and signatures. The specialist is responsible for validating software systems and processes, documenting compliance activities, and helping companies pass regulatory audits. Typically, they work on a contract or project basis to address specific compliance needs.

What are some common challenges faced by professionals working in Temp 21 CFR Part 11 validation roles?

Professionals in Temp 21 CFR Part 11 validation roles often encounter challenges such as keeping up-to-date with evolving regulatory requirements, ensuring that electronic systems remain compliant throughout frequent software updates, and collaborating effectively with cross-functional teams like IT, QA, and operations. Additionally, balancing thorough documentation with project timelines can be demanding, as every validation activity must be meticulously recorded to pass audits. Building strong communication skills and staying proactive with regulatory trends can help mitigate these challenges and enhance success in the role.
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Temp 21 Cfr Part 11 Validation jobs near you
Infographic showing various Temp 21 Cfr Part 11 Validation job openings in the United States as of August 2026, with employment types broken down into 98% Full Time, and 2% Part Time. Highlights an 99% Physical, and 1% Remote job distribution, with an average salary of $104,945 per year, or $50.5 per hour.

Validation Engineer/CSV Engineer

Katalyst Healthcares & Life Sciences

Walnut Creek, CA

Contractor

Re-posted 24 days ago

Job description

Company Description
  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description

Job Description:

  • Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
  • Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
  • Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
  • Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
  • Creation and review of validation deliverables including but not limited to.

Responsibilities:

  • Requirement Specifications (User, Functional).
  • Plan.
  • Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
  • Traceability Matrix.
  • Periodic Reviews.
  • System Retirement/Decommissioning.
  • Execution of Dry/Test protocol run.
  • Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
  • Perform System Retirement/Decommissioning of systems not in business .
  • Work closely with software development and IT teams to establish best practices for quality and compliance.
  • Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
  • Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.

Requirements:

  • A Minimum bachelor's degree in engineering, Science or related technical field.
  • Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
  • Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
  • Experience with non-product software validation, including tools for development, testing, and maintenance.
  • Good knowledge and experience of CSV activities but not limited to.
  • GxP and 21 CFR Part 11 applicability/criticality assessment.
  • Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
  • Execution of Dry/Test protocols.
  • Conduct Periodic Reviews of systems.
  • Perform System Retirement of systems that are not in business.
  • Understanding of Medical Device Quality and Compliance.
  • Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
  • Working experience in Product Lifecycle Management (PLM) too.
  • sound knowledge of computer system development lifecycles.
  • Knowledge of JIRA, JAMA software and test automation is a plus. "
  • Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304.
Additional Information

All your information will be kept confidential according to EEO guidelines.

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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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