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Validation Consultant Jobs (NOW HIRING)

Cryoport, Inc.

Validation Engineer

Irvine, CA · On-site

The Validation Engineer - Consulting Services will support the Consulting Services team's offerings around shipper, packaging, and shipping lane qualifications across temperature sensitive supply ...

Actalent

Validation Engineer

Paramus, NJ

Collaborate closely with cross-functional teams, including internal engineers, quality, manufacturing, and external consulting partners, to support validation activities and project milestones.

CYNET SYSTEMS

Validation Lead

Raritan, NJ · On-site

$48 - $53/hr

Experience in writing and executing documentation for all aspects of the validation deliverables (e ... S. states and Canada, we support thousands of consultants through our expansive, high-performing ...

Spruce Infotech

Validation Expert

Fort Worth, TX · On-site

... consulting services organization and/or industry experience. * Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, Data ...

RD Partners

Validation Engineer

Tucson, AZ · On-site

$39 - $42/hr

R&D Partners is seeking to hire a Validation Engineer in Tucson, AZ . Your main responsibilities as ... Our team offers well over 200 years of combined staffing experience providing consulting, direct ...

Stem Xpert

Validation Engineer

Hillsboro, OR

It also offers outsourcing, consulting, recruitment, career transition, and vendor management ... Validation Engineer location: Hillsboro, OR Duration: 6 + months Proficient in Linux ...

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How much do validation consultant jobs pay per hour?

As of Aug 15, 2026, the average hourly pay for validation consultant in the United States is $58.47, according to ZipRecruiter salary data. Most workers in this role earn between $51.44 and $65.14 per hour, depending on experience, location, and employer.

How does a validation consultant typically collaborate with cross-functional teams during a project?

Validation Consultants frequently work alongside quality assurance, engineering, and regulatory teams to ensure processes and products meet industry standards. They participate in meetings to clarify requirements, coordinate testing schedules, and address compliance issues. Effective communication and documentation are key, as they must translate technical validation findings into actionable information for both technical and non-technical stakeholders. This collaborative approach is essential to streamline project timelines and maintain regulatory compliance.

What is the difference between Validation Consultant vs Quality Assurance Specialist?

AspectValidation ConsultantQuality Assurance Specialist
CredentialsOften requires certifications like GxP, CSV, or industry-specific validation trainingTypically holds certifications in QA, ISO standards, or industry-specific quality management
Work EnvironmentWorks mainly in regulated industries like pharmaceuticals, biotech, or medical devices, focusing on validation processesWorks across various industries ensuring product and process quality, often in manufacturing or service sectors
Employer & Industry UsageCommonly employed by pharmaceutical, biotech, and medical device companies for validation projectsEmployed broadly in manufacturing, software, healthcare, and other sectors for quality oversight

While both roles focus on quality and compliance, Validation Consultants specialize in validation processes for regulated industries, ensuring systems and equipment meet standards. Quality Assurance Specialists oversee overall quality systems and compliance across various sectors. The roles often overlap but differ mainly in scope and industry focus.

What are the key skills and qualifications needed to thrive as a validation consultant, and why are they important?

To thrive as a Validation Consultant, you need expertise in validation protocols, regulatory compliance (such as FDA or EMA guidelines), and a relevant science or engineering degree. Familiarity with validation lifecycle documentation, risk assessment tools, and systems like GMP software is typically required. Strong analytical thinking, attention to detail, and effective communication skills set top candidates apart in this role. These skills are crucial for ensuring product quality, regulatory adherence, and smooth project execution within highly regulated industries.

What is a validation consultant?

A validation consultant advises a company or manufacturer on how to set up a new production project. Their job duties include testing the quality of the process, ensuring that all industry standards are met, and providing recommendations on how to set up the project efficiently. Qualifications for this career typically include a bachelor’s degree in electrical or mechanical engineering and prior job experience. Strong verbal and written communication skills, in addition to a background in analytical problem-solving and knowledge of budgeting and finance are important for success in a validation consultant role.

What is a validation consultant?

A Validation Consultant is a professional who specializes in ensuring that processes, systems, or products in industries like pharmaceuticals, biotechnology, or manufacturing meet regulatory standards and function as intended. They design and execute validation protocols, review documentation, and help companies comply with industry regulations such as FDA or EMA guidelines. Validation Consultants often work on projects involving equipment qualification, process validation, and software validation to ensure quality and compliance. Their expertise helps organizations avoid costly errors and regulatory issues. They may work independently or as part of a consulting firm.
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Validation Consultant jobs near you
Infographic showing various Validation Consultant job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 7% Part Time, and 5% Contract. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution, with an average salary of $121,624 per year, or $58.5 per hour.

Validation Engineer

Cryoport, Inc.

Irvine, CA • On-site

Full-time

Medical, Retirement

Re-posted 16 days ago

Job description

Cryoport Systems is a comprehensive supply chain partner for the life sciences industry, delivering specialized solutions to meet the challenges of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health markets. Our offerings span logistics, BioServices and biostorage, cryopreservation, and consulting, ensuring the highest standards of quality and reliability for sensitive materials. With our expansive platform of management solutions and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™ by supporting certainty and precision in the supply chain, whether advancing groundbreaking therapies, supporting families on their reproductive journeys, or enhancing animal health programs.
POSITION SUMMARY:
The Validation Engineer - Consulting Services will support the Consulting Services team's offerings around shipper, packaging, and shipping lane qualifications across temperature sensitive supply chains. This is a client-facing role within the Cryoport Systems Consulting Services department that is responsible for engaging in client discussions, performing qualifications, and developing technical reports.
PRIMARY RESPONSIBILITIES (include but are not limited to):
Participate and oversee internal Consulting Services qualification processes including:
  • Assist in the development of validation procedures.
  • Perform internal validations including developing validation protocols and reports, preparing equipment, and documenting & analyzing test results.
  • Support project creations for shipping lane qualifications, packaging configurations, systemized operational qualifications (physical and/or thermal performance testing), and shipping feasibility studies.
  • Manage qualification activities for Consulting Services' Consulting Services client related projects.
  • Work as a team with all Consulting Services team members.
  • Engage with clients presenting validation plans in client collaboration meetings.
  • Develop and customize customer centric quality driven protocols.
  • Assists with coordination between external third-party testing laboratories to ensure protocol execution, timelines, and quality metrics are achieved.
  • Evaluate, document, and articulate client specific results utilized strong communication skills.
  • Assist in optimizing existing protocols, processes, and reporting for all validation activities
  • Engage in continuous process improvement areas within Cryoport Systems Consulting Services
  • Support cross-organizational departments as needed.

COMPETENCIES & PERSONAL ATTRIBUTES:
  • Professional with high attention to detail who focuses on client success.
  • Strong Communication Skills ñ written and verbal.
  • Analytical thinker with proficient skills in math, statistics, and data analysis applications
  • Strong organizational skills to manage multiple projects within overlapping timeframes.
  • Team player with ability to manage internal and external teams to achieve deliverables.
  • Self-motivated with initiative to self-learn to fill in knowledge gaps and expand contributions.

QUALIFICATIONS AND EDUCATION REQUIREMENTS:
  • BA/BS degree (in Life Sciences/Biopharma or a related healthcare field is highly preferred but not required)
  • 2+ years of experience in Biopharmaceuticals, Medical Device Industry (specifically Cell & Gene Therapies is highly preferred)
  • 2+ Years of Experience in writing professional documentation with customer-facing materials.
  • Preferred experience with ISO, IATA, ASTM and ISTA standards relating to the pharmaceutical supply chain.
  • Preferred experience with Equipment and Process Validation using DQ, IQ, OQ, and PQ.
  • Knowledge of cGMP requirements, FDA and ICH guidelines is highly preferred.
  • Experience using Excel, creating pivot tables, graphs and customer digestible and meaningful visual and tabular analytics.
  • Proficiency in Microsoft Office (Word, Excel, Power Point, Teams)
  • Project Management skills/ training is desirable.

PREFERRED SKILLS:
Understanding of:
  • Cold Chain and temperature-sensitive logistics.
  • Packaging testing and qualification.
  • (GDP) Good Distribution Practices.
  • USP 36 (Chapter 1079) Good Storage and Distribution Practices for Drug Products.
  • ISO 21973 Biotechnology
  • General requirements for transportation of cells for therapeutic use.
  • 21CFR Part 210 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs
  • 21CFR Part 211 cGMP for Finished Pharmaceuticals.

Compensation: Up to $120,000 depending on experience + bonus, stock, 401k match, benefits, etc.
Cryoport Systems is an Equal Opportunity Employer offering competitive compensation with a generous benefits package that includes health insurance, a 401K with company match and stock equity (Nasdaq: CYRX).

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