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Validation Engineer Biomedical Jobs (NOW HIRING)

Validation Engineer We are seeking a hands-on Validation Engineer to implement, validate, and ... Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering ...

... Biomedical Engineering or related field • 5+ years of validation/testing/engineering experience • Strong communication & teamwork skills • Experience in fast-paced, cross-functional ...

Validation Engineer IV

Lakeside, CA · On-site

$55 - $60/hr

Validation Engineer IV Location: 3200 Lakeside Drive, Santa Clara, CA 95054 Duration: 6 Months Work ... Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field. * Minimum ...

... Biomedical, or Industrial Engineering. To succeed in this role, you need strong technical judgment ... supporting consistent validation practices across sites. Just as importantly, you value ...

... Biomedical, or Industrial Engineering. To succeed in this role, you need strong technical judgment ... supporting consistent validation practices across sites. Just as importantly, you value ...

Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, Biomedical Engineering, or Engineering. * Six Sigma certification. * 3 years of validation experience in a cGMP Device ...

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, Biomedical Engineering, or Engineering. * Six Sigma certification. * 3 years of validation experience in a cGMP Device ...

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How much do validation engineer biomedical jobs pay per hour?

As of Jun 4, 2026, the average hourly pay for validation engineer biomedical 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 are the key skills and qualifications needed to thrive as a Validation Engineer in Biomedical, and why are they important?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What are some typical challenges faced by Validation Engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What does a Validation Engineer do in the biomedical field?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

More about Validation Engineer Biomedical jobs
What cities are hiring for Validation Engineer Biomedical jobs? Cities with the most Validation Engineer Biomedical job openings:
What states have the most Validation Engineer Biomedical jobs? States with the most job openings for Validation Engineer Biomedical jobs include:
Infographic showing various Validation Engineer Biomedical job openings in the United States as of May 2026, with employment types broken down into 99% Full Time, and 1% Part Time. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Validation Engineer

Stark Pharma Solutions Inc

Concord, NC • On-site

Contractor

Posted 2 hours ago


Job description

Job Title: Validation Engineer
Location: Concord, NC
Duration: Long Term

Job Summary

We are seeking a motivated and detail-oriented Validation Engineer to support validation activities within a GMP-regulated biopharmaceutical manufacturing environment. The Validation Engineer will be responsible for equipment qualification, process validation, utility validation, and cleaning validation activities to ensure compliance with FDA, cGMP, and industry standards.

The ideal candidate will collaborate with Manufacturing, Quality Assurance, Engineering, and Regulatory teams to support production operations, maintain validated systems, and ensure regulatory compliance across the facility.

Key Responsibilities

  • Develop, execute, and review validation protocols and reports including IQ, OQ, and PQ documentation
  • Support equipment qualification activities for biopharmaceutical manufacturing equipment and laboratory systems
  • Perform process validation for upstream and downstream manufacturing processes
  • Execute cleaning validation and utility qualification activities including HVAC, purified water, compressed gases, and cleanroom systems
  • Ensure compliance with FDA, cGMP, GDP, and company quality standards
  • Support computerized systems validation (CSV) activities when required
  • Participate in deviation investigations, root cause analysis, CAPA, and change control processes
  • Collaborate with cross-functional teams during equipment installation, commissioning, and technology transfer projects
  • Maintain validation lifecycle documentation including SOPs, Validation Master Plans (VMP), and risk assessments
  • Assist during internal audits and regulatory inspections by providing validation documentation and technical support
  • Identify and implement continuous improvement opportunities within validation and manufacturing processes

Required Qualifications

  • Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Biotechnology, or related field
  • 3+ years of validation experience in biopharmaceutical, pharmaceutical, or regulated manufacturing industries
  • Strong understanding of cGMP, FDA regulations, and validation principles
  • Experience with IQ/OQ/PQ protocol execution and report generation
  • Knowledge of process validation, cleaning validation, and utility qualification
  • Familiarity with deviation management, CAPA, and change control systems
  • Strong technical writing and documentation skills
  • Excellent communication, analytical, and problem-solving abilities