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21 Cfr Part 11 Validation Jobs (NOW HIRING)

Asterism IT Solutions

OT Security Architect

Bedford, IN · On-site

$58.25 - $75.25/hr

Ensure compliance with GMP & FDA 21 CFR Part 11 (audit trails, electronic records, RBAC). Support Computer System Validation (CSV) documentation (URS/NFR/FS/DS/IQ/OQ/PQ). Define patch management and ...

Southern Research

Senior Validation Analyst

Birmingham, AL

$108K - $109K/yr

Senior Validation Analyst Southern Research + You Discover a career where your work truly matters ... This role requires strong knowledge of regulatory requirements and guidance (e.g., 21 CFR Part 11 ...

Katalyst CRO

CSV Engineer

Somerset, NJ · On-site

... GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle • Support deviation investigations, CAPAs, and change control activities related to validated systems • ...

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

As of Aug 9, 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 21 CFR Part 11 Validation?

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 skills and qualifications are needed for 21 CFR Part 11 Validation?

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 21 CFR Part 11 Validation?

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 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 $108,152 per year, or $52 per hour.

OT Security Architect

Asterism IT Solutions

Bedford, IN • On-site

$58.25 - $75.25/hr

Other

Posted 4 days ago

Job description

Job title – OT Security Architect
Work location - Bedford, Indiana--Hybrid
Contract duration – 6 months
 
No CPT,OPT,H1B
Mandatory skills - The role focuses on Rockwell PLC (ControlLogix/CompactLogix) systems, Ignition SCADA, and compliance with EU Cyber Resilience Act (CRA), IEC 62443/ISA99, ISA 95, GMP, and FDA 21 CFR Part 11.
Minimum years of experience needed in the required skills- 8-10 years
Minimum over all work experience required – 10 years
Domain – Cyber Security
Preferred Certifications
IEC 62443 Cybersecurity Expert
GICSP / CISSP
Rockwell Automation certifications

Complete job description –
Define and maintain global OT reference architecture (Purdue model, zones & conduits, DMZ).
Lead CRA implementation and gap assessments for OT systems.
Secure and harden Rockwell PLCs and Ignition SCADA environments.
Perform OT cyber risk assessments and threat modelling.
Implement secure configuration baselines for servers and engineering workstations.
Ensure compliance with GMP & FDA 21 CFR Part 11 (audit trails, electronic records, RBAC).
Support Computer System Validation (CSV) documentation (URS/NFR/FS/DS/IQ/OQ/PQ).
Define patch management and vulnerability handling processes for validated OT systems.
Support audit readiness and regulatory inspections.
Interview mode -  Virtual

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