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Intern 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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Intern 21 Cfr Part 11 Validation information

What is the difference between Intern 21 Cfr Part 11 Validation vs Quality Assurance Intern?

AspectIntern 21 Cfr Part 11 ValidationQuality Assurance Intern
CertificationsKnowledge of 21 CFR Part 11 regulations, validation protocolsUnderstanding of QA processes, industry standards
Work EnvironmentRegulatory compliance, validation testing in regulated labsQuality control, process audits in manufacturing or labs
Employer & IndustryPharmaceutical, biotech, or medical device companiesPharmaceutical, biotech, or manufacturing sectors

Intern 21 Cfr Part 11 Validation focuses on ensuring electronic records and signatures comply with FDA regulations, involving validation protocols. Quality Assurance Interns concentrate on overall quality processes, audits, and standards. While both roles support compliance and quality, the validation role is more specialized in regulatory validation tasks, whereas QA interns handle broader quality assurance activities.

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Intern 21 Cfr Part 11 Validation jobs near you
Infographic showing various Intern 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.

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.