ZipRecruiter

Log In

1

Temp 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 ...

next page

Showing results 1-20

All Jobstmp JobsTemp 21 Cfr Part 11 Validation Jobs

Temp 21 Cfr Part 11 Validation information

See salary details

$15

$50

$75

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

As of Aug 18, 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 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 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 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.

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.

More about Temp 21 Cfr Part 11 Validation jobs

What cities are hiring for Temp 21 Cfr Part 11 Validation jobs?

Cities with the most Temp 21 Cfr Part 11 Validation job openings:

What are the most commonly searched types of 21 Cfr Part 11 Validation jobs?

The most popular types of 21 Cfr Part 11 Validation jobs are:

What states have the most Temp 21 Cfr Part 11 Validation jobs?

States with the most job openings for Temp 21 Cfr Part 11 Validation jobs include:

What job categories do people searching Temp 21 Cfr Part 11 Validation jobs look for?

The top searched job categories for Temp 21 Cfr Part 11 Validation jobs are:

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.

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.

Apply