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Qa Validation Engineer Jobs (NOW HIRING)

Initial Therapeutics, Inc.

NY · On-site

$78K - $107K/yr

We are seeking a Sr. QA Validation Specialist to join our Quality Assurance team. As the Senior QA Validation Specialist, you will validate/qualify equipment, systems, and processes in accordance ...

Scorpion Therapeutics

NY · On-site

$78K - $107K/yr

S. in life sciences or related field; proven experience may substitute. * QA Validation Specialist: 4+ years of experience. * Sr. QA Validation Specialist: 6+ years of experience. Benefits (if part ...

Regeneron Pharmaceuticals, Inc

NY · On-site

$78K - $107K/yr

We are seeking a Sr. QA Validation Specialist to join our Quality Assurance team. As the Senior QA Validation Specialist, you will validate/qualify equipment, systems, and processes in accordance ...

FUJIFILM Biotechnologies

Position OverviewThe Senior QA Engineer, Validation helps drive the Quality oversight for Commissioning, Qualification, and Validation (CQV) processes. The position also oversees, reviews, and ...

Aequor

Specialist QA - Validation, cGMP

Woburn, MA · On-site

Company Description Engineering Job Title- Specialist QA Location- Woburn, MA Duration - 12 months with possible extension Key Skills - QA Pharma, Bio, biopharma, cGMP, validation, conformance, CAPAs ...

Danaher

Manager Quality Assurance, Validation

Chaska, MN · On-site

$130K - $160K/yr

The Quality Assurance Manager , Validations is located in Chaska, MN and reports to the Director of Quality Assurance. Our analyzers and reagents are medical laboratory devices used to calculate the ...

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How much do qa validation engineer jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for qa validation engineer 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 a QA Validation Engineer?

QA Validation Engineers are professionals responsible for ensuring that products, systems, or software meet specified quality and regulatory standards before they are released or deployed. They design and execute validation protocols, document results, and identify any issues or non-conformities during the testing process. Their role is crucial in industries like pharmaceuticals, manufacturing, and software, where compliance and reliability are essential. QA Validation Engineers collaborate closely with development, production, and regulatory teams to ensure that products are safe, effective, and meet all necessary guidelines.

How does a QA Validation Engineer typically collaborate with cross-functional teams during product development?

As a QA Validation Engineer, you’ll work closely with development, regulatory, and operations teams to ensure products meet quality and compliance standards. You’ll participate in project meetings, review technical documentation, and provide input on test strategies and validation protocols. Effective communication and problem-solving are essential, as you may need to clarify requirements, address issues found during validation, and coordinate testing activities. This collaborative environment helps ensure that products are released on schedule and comply with industry regulations.

What are the key skills and qualifications needed to thrive as a QA Validation Engineer, and why are they important?

To thrive as a QA Validation Engineer, you need a solid understanding of quality assurance methodologies, validation protocols, and a relevant technical degree such as in engineering or life sciences. Familiarity with industry regulations (such as FDA or ISO standards), validation management software, and documentation tools is typically required. Attention to detail, analytical thinking, and strong communication skills help you excel in identifying compliance gaps and collaborating with cross-functional teams. These skills and qualities are crucial to ensure products meet regulatory requirements and maintain high standards of quality and safety.

What is the difference between Qa Validation Engineer vs QA Tester?

AspectQa Validation EngineerQA Tester
CertificationsISTQB, CQE, or similarISTQB Foundation, CSTE
Work EnvironmentRegulatory, validation-focused industries like pharma, biotechSoftware development, IT, web applications
ResponsibilitiesValidating systems, ensuring compliance, writing validation protocolsExecuting test cases, identifying bugs, reporting issues

While both roles focus on quality assurance, Qa Validation Engineers primarily work on validating systems for compliance and regulatory standards, often in industries like pharmaceuticals. QA Testers concentrate on testing software functionality and identifying bugs during development. The roles overlap in testing skills but differ in scope and industry focus.

Are QA Validation Engineers in demand?

QA Validation Engineers are in demand across industries such as pharmaceuticals, biotech, and manufacturing, where regulatory compliance and quality assurance are critical. The role requires knowledge of validation processes, testing protocols, and often involves working with tools like GxP standards and validation software, making experienced professionals highly sought after.

Do validation engineers make good money?

Validation engineers, including QA validation engineers, typically earn competitive salaries that vary by industry, experience, and location. They often require knowledge of testing tools, validation protocols, and quality standards, which can influence compensation levels. Overall, validation engineering is considered a well-paying profession within quality assurance and engineering fields.
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Qa Validation Engineer jobs near you
Infographic showing various Qa Validation Engineer job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 87% Full Time, 9% Part Time, and 3% Contract. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Specialist, Quality Assurance Validation

Bothell, WA • On-site

Lyell Immunopharma
Biotechnology Research and Development • 201 - 500 employees
Learn more about Lyell Immunopharmaexternal

$96K - $120K/yr

Full-time

Re-posted 17 days ago

Job description

The Quality Assurance Specialist provides QA oversight for Facility, Equipment, Utility (FEU), and Computer System (CS) programs in a cell therapy manufacturing environment, with accountability for review, approval, escalation, and lifecycle compliance activities that support GMP readiness and sustained operational control.

This role serves as the Quality representative on cross-functional project teams and ensures Facility, Equipment, Utility, and Computer System activities are planned, executed, documented, and maintained in compliance with GMP requirements while supporting clinical and commercial operating timelines.

KEY ROLES AND RESPONSIBILITIES:Commissioning, Qualification, and Validation
  • Provide QA compliance oversight for Facility, Equipment, Utility, and Computer System qualification and validation projects.
  • Review and approve validation plans, User Requirement Specifications (URS), protocols (IQ/OQ/PQ), and summary reports for equipment and systems.
  • Maintain oversight of the qualified and validated state of Facility, Equipment, Utility , and computer systems through periodic review, requalification, deviation review, and change management.
  • Create and manage qualification and validation project schedules.
Facility, Equipment, and Utility Oversight
  • Support onboarding of new Facility, Equipment, and Utility assets by approving initial release requirements and defining quality expectations for lifecycle management.
  • Provide QA oversight for the calibration and maintenance programs to ensure ongoing GMP compliance and operational readiness.
  • Review and approve work plans including procedure, test points, tolerances, and acceptance criteria.
  • Review and approve asset removal, return-to-service activities, and associated quality documentation.
  • Review and approve on-demand work orders for unplanned events and repairs.
Quality Systems:
  • Review and approve Standard Operating Procedures related to Facility, Equipment, Utility, and Computer System operation and maintenance.
  • Review and approve change controls, deviations, and Corrective and Preventive Actions (CAPAs) related to Facility, Equipment, Utility , and Computer Systems.
KNOWLEDGE SKILLS AND ABILITIES:
  • Understanding of requirements and expectations for compliant Facility, Equipment, and Utility programs including commissioning/qualification, calibration, and maintenance.
  • Ability to work effectively both independently and cross-functionally.
  • Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
  • Excellent communication, emotional intelligence and interpersonal skills.
  • Familiar with quality management systems (e.g. deviations, CAPAs, change management).
  • Curious and proactive mindset with a continuous improvement orientation.
REQUIRED EDUCATION AND EXPERIENCE:
  • Bachelor's degree in life sciences or a related technical discipline with a minimum of 5 years of experience in a GMP biopharmaceutical manufacturing environment or equivalent combination of relevant education, training, and experience,
PREFERRED EXPERIENCE:
  • Prior experience in a Quality Assurance oversight role for Facility, Equipment, and Utility qualification and management.
  • Experience with computer system validation.
  • Previous experience using Blue Mountain computerized maintenance management software.
  • Experience with cell therapy and/or lentiviral manufacturing operations.
  • Experience in commercial manufacturing and post-approval lifecycle management.
PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:

  • Stand and step over a gowning bench (12-24") and aseptically don head-to-toe non-sterile and sterile gowns.
SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:

While this position is primarily Monday - Friday, occasional off-shift work, weekend work, and holiday work may be required due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible.

 
The salary range for this position is $96,000 to $120,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell's compensation practices and an applicant's qualifications and experience. Employees are also eligible to participate in Lyell's Equity Incentive Plan. 
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
 
We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply.

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