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21 Cfr Part 11 Validation Jobs (NOW HIRING)

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 ...

Intellectt INC

Validation Lead

Raleigh, NC · On-site

Ensure validation deliverables comply with cGMP, FDA, 21 CFR Part 11, GAMP 5, and company quality procedures . * Coordinate with cross-functional teams including QA, Manufacturing, Engineering, QC, ...

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

As of Jul 27, 2026, the average hourly pay for 21 cfr part 11 validation in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What is a 21 CFR Part 11 Validation job?

A 21 CFR Part 11 Validation job involves ensuring that electronic records and signatures comply with FDA regulations for reliability, security, and data integrity. Professionals in this role validate computer systems, software, and processes used in regulated industries like pharmaceuticals and biotechnology. They create and execute validation protocols, conduct risk assessments, and document compliance efforts. Their work helps organizations meet regulatory requirements and avoid issues related to electronic data integrity.

What are the key skills and qualifications needed to thrive in the 21 Cfr Part 11 Validation position, and why are they important?

To thrive in a 21 CFR Part 11 Validation role, you need in-depth knowledge of FDA regulations, validation protocols, and quality compliance standards, often supported by a degree in life sciences, engineering, or a related field. Experience with computerized systems validation (CSV) tools, risk management methodologies, and familiarity with common validation documentation systems is highly valuable, and certifications such as ASQ or PMP can be an advantage. Strong analytical thinking, attention to detail, and effective communication skills are crucial for preparing documentation and collaborating with cross-functional teams. These capabilities enable accurate validation processes, ensure regulatory compliance, and minimize risks in regulated environments.

What are the common challenges faced in a 21 CFR Part 11 Validation role?

One of the common challenges in a 21 CFR Part 11 Validation role is keeping up with evolving regulatory requirements while ensuring all computerized systems meet compliance standards. You'll often need to manage multiple projects simultaneously, coordinate with IT, QA, and production teams, and address any gaps in existing processes or documentation. Additionally, troubleshooting integration issues between systems and maintaining meticulous records can require both technical expertise and organized workflows. Overcoming these challenges not only enhances your problem-solving skills but also strengthens your value as a validation professional.

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21 Cfr Part 11 Validation jobs near you
Infographic showing various 21 Cfr Part 11 Validation job openings in the United States as of July 2026, with employment types broken down into 86% Full Time, and 14% Contract. Highlights an 100% In-person job distribution, with an average salary of $108,152 per year, or $52 per hour.
Validation Engineer/CSV Engineer

Validation Engineer/CSV Engineer

Katalyst Healthcares & Life Sciences

Walnut Creek, CA

Contractor

Posted 6 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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