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Temp 21 Cfr Part 11 Validation Jobs (NOW HIRING)

Sigan America LLC

Validation Engineer

Ottawa, IL · On-site

$90K - $100K/yr

Senior Validation Engineer Location: Ottawa, Illinois Employment Type: Full-Time About the Position ... Computerized Systems and 21 CFR Part 11 Compliance Qualifications Required * Bachelor's degree in ...

FITS LLC

Laboratory Validation Specialist

Anasco, PR · On-site

$70 - $100/hr

Data Integrity (ALCOA+), GMP, GDP, GxP, and 21 CFR Part 11 compliance requirements. * Change Control, Risk Assesments, and FMEA methodologies. * LIMS, Empower, and Validation Documentation ...

E*Pro, Inc.

Jr. Validation Engineer

Saint Louis, MO · On-site

Temporary, entry-level position to mitigate expected validation workload Review requirements ... 21 CFR Part 11 Electronic Records and Electronic Signatures Strong analytical, problem-solving ...

Prophecy Technologies

R&D CSV Engineer

Wilmington, DE · On-site

Ensure strict adherence to regulatory standards including 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, and ITIL. * Author critical validation documentation such as User Requirement ...

Shimento, Inc.

CQV Validation Specialist

Bend, OR · On-site

CQV Validation Specialist / CSV/CQV Specialist Location: Bend, OR (Onsite) Duration: 6-9 Month ... Ensure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

$65 - $90/hr

... validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across ...

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

As of Sep 6, 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.

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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 93% Full Time, 3% Part Time, and 4% Contract. Highlights an 85% Physical, 5% Hybrid, and 10% Remote job distribution, with an average salary of $104,945 per year, or $50.5 per hour.

S/4HANA CSV Validation Lead - Life Sciences Expert (Foster City)

Infosys

Foster City, CA • On-site

Full-time

Posted 2 days ago

New

Infosys rating

7.0

Company rating: 7.0 out of 10

Based on 62 frontline employees who took The Breakroom Quiz

153rd of 226 rated it services

Job description

Infosys is seeking a senior Consultant for Computerized System Validation (CSV) leadership in Life Sciences, focusing on SAP S/4HANA validations from ECC migrations to cloud validation. The role involves risk-based validation, adherence to 21 CFR Part 11 and GxP, and cross-functional collaboration with Quality and Compliance teams.

You will coordinate validation deliverables, work with SAP modules (FI/CO, MM, QM, MDG) and ensure audit readiness while supporting client strategic SAP

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