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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 ...

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 ...

Tailored Management

Validation Engineer 2

Bend, OR · On-site

$70.92 - $99.29/hr

Validation Engineer 2 CSV/CQV Specialist Location: 1201 NW Wall Street, Bend, OR 97703 Work Model ... Ensure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and ...

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 ...

Biovire

Director, Validation

Brighton, MI · On-site

$100K - $120K/yr

Establish and oversee the Computer Systems Validation program, including application of GAMP 5, data integrity principles, electronic records/signatures requirements, and 21 CFR Part 11.Provide ...

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 ...

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21 Cfr Part 11 Validation information

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

As of Sep 3, 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 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 $108,152 per year, or $52 per hour.

Validation Engineer

Sigan America LLC

Ottawa, IL • On-site

$90K - $100K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 11 days ago

Key responsibilities

  • Develop, review, and execute IQ, OQ, and PQ validation protocols.

  • Plan and execute validation activities for new equipment, facilities, utilities, and manufacturing processes.

  • Support engineering change controls and assess validation impact for equipment and process changes.

Job description

Senior Validation Engineer

Location: Ottawa, Illinois
Employment Type: Full-Time

About the Position

We are seeking an experienced Senior Validation Engineer to lead validation activities supporting our cGMP manufacturing operations. This role is responsible for validating equipment, facilities, utilities, manufacturing processes, and computerized systems while ensuring compliance with FDA cGMP requirements and industry best practices.

The ideal candidate has a strong technical background in pharmaceutical, medical device, cosmetic, or regulated manufacturing environments and enjoys working cross-functionally with Engineering, Quality, Manufacturing, Regulatory Affairs, Maintenance, and R&D.

Key Responsibilities

  • Develop, review, and execute IQ, OQ, and PQ validation protocols.
  • Plan and execute validation activities for new equipment, facilities, utilities, and manufacturing processes.
  • Support new product launches and continuous process improvement initiatives.
  • Prepare validation reports and maintain complete validation documentation.
  • Lead equipment qualification and process validation projects from planning through implementation.
  • Support engineering change controls and assess validation impact for equipment and process changes.
  • Perform periodic reviews and revalidation of equipment, utilities, and manufacturing processes.
  • Ensure compliance with FDA cGMP regulations, ISPE guidance, and internal quality standards.
  • Maintain validation records, equipment logbooks, and supporting documentation.
  • Collaborate with Maintenance, Engineering, Manufacturing, Quality Assurance, Regulatory Affairs, and R&D to resolve technical issues and implement improvements.
  • Identify opportunities to improve validation systems, documentation, and overall compliance.

Systems & Equipment Experience

Experience validating one or more of the following is highly desirable:

  • HVAC systems
  • Purified Water / RODI Water Systems
  • Compressed Air and Gas Systems
  • Boilers and Chillers
  • Temperature- and Humidity-Controlled Rooms
  • Refrigerators, Freezers, and Incubators
  • Manufacturing Equipment
  • Laboratory Equipment
  • Computerized Systems and 21 CFR Part 11 Compliance

Qualifications

Required

  • Bachelor's degree in Engineering, Life Sciences, or a related technical field (or equivalent experience).
  • 3–5+ years of validation experience in a pharmaceutical, medical device, cosmetic, or other FDA-regulated manufacturing environment.
  • Experience developing and executing IQ/OQ/PQ protocols.
  • Experience with equipment, facility, utility, and process validation.
  • Experience with engineering change controls and validation documentation.
  • Strong technical writing and documentation skills.
  • Excellent organizational skills with exceptional attention to detail.
  • Ability to manage multiple projects while meeting deadlines.

Preferred

  • Experience performing temperature mapping of refrigerators, freezers, incubators, warehouses, or controlled environments.
  • Experience with software validation and 21 CFR Part 11 compliance.
  • Experience completing validation periodic reviews.
  • Knowledge of risk-based validation methodologies.
  • Familiarity with Lean Manufacturing or Continuous Improvement initiatives.

What We're Looking For

The successful candidate is a hands-on validation professional who enjoys solving technical problems, improving manufacturing processes, and working collaboratively across departments. This individual is organized, detail-oriented, and committed to maintaining the highest standards of quality and regulatory compliance.

Competitive salary and comprehensive benefits package offered based on experience.

Company Description

About Us
Fast growing liquid pour contract manufacturer of premium health and beauty products.