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Validation Consultant Jobs (NOW HIRING)

BeiGene USA

Senior Engineer I, Validation

Hopewell, VA · On-site

May manage validation consultants on a large project basis, as needed. * Leading and Managing projects for the validation of equipment, processes, and products to meet all safety, quality, regulatory ...

Cryoport

Validation Engineer

Irvine, CA

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

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 ...

Stefanini

Validation Specialist

Marion, NC · Hybrid

Stefanini is looking for Validation Specialist in Marion, NC (Hybrid) For quick Apply, please reach ... Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 ...

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How much do validation consultant jobs pay per hour?

As of Jun 14, 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.

How much does a validation engineer make?

A validation engineer at Pfizer typically earns between $70,000 and $100,000 annually, depending on experience, location, and certifications. The role involves ensuring compliance with regulatory standards and often requires knowledge of GMP, validation protocols, and relevant software tools.

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 does a validation consultant do?

A validation consultant evaluates and verifies that manufacturing processes, equipment, and systems comply with industry standards and regulatory requirements. They develop validation protocols, perform testing, and document results to ensure product quality and process consistency, often working with tools like validation software and adhering to Good Manufacturing Practices (GMP).

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.

How much does a validation specialist make in the US?

A validation specialist in the US typically earns between $60,000 and $90,000 annually, depending on experience, industry, and location. Salaries can be higher with certifications such as GxP or CQE and experience with validation tools and protocols.

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.

What are high paying consultant jobs?

High-paying consultant jobs often include management consultants, IT consultants, and financial advisors, with salaries varying based on experience, industry, and location. Specialized skills, certifications, and experience in niche areas can significantly increase earning potential for consultants.
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Validation Consultant jobs near you
Infographic showing various Validation Consultant job openings in the United States as of June 2026, with employment types broken down into 33% Full Time, and 67% Contract. Highlights an 67% In-person, and 33% Hybrid job distribution, with an average salary of $121,624 per year, or $58.5 per hour.
Senior Engineer I, Validation

Senior Engineer I, Validation

BeiGene, Inc.

Pennington, NJ • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 4 days ago

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
Engages in the day-to-day activities of the Validation function, ensuring the successful management of related activities and large projects. Supports Validation objectives, whilst adhering to regulatory compliance and achieving commercial success. This is a site-based position supporting the facility and will required gowning into the manufacturing suites.
Ensures the Validation function supports operational needs and ensures regulatory compliance requirements are met. Works to support Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and objectives, whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs needed to support the business. Works to support both internal GMP audits and Health Authority audits. Supports Validation related tasks as assigned by Management.
Responsibilities
  • Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP's, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning/sterilization validation.
  • Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, SAT, IQ, OQ, PQ) etc.
  • Ensuring that the Validation department meets or improves key performance indicators (KPIs). Works to ensure all validation projects are on time and on budget. Ensures adequate validation resources. May manage validation consultants on a large project basis, as needed.
  • Leading and Managing projects for the validation of equipment, processes, and products to meet all safety, quality, regulatory and operational requirements
  • Review of equipment specification/design/procurement/installation and validation.
  • Project planning and execution including scheduling, task management, milestone planning and reporting
  • Generation, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures
  • Employee will be required to work closely with both manufacturing, quality, and engineer associates.
  • Maintaining the validation sample management, assessing the requirements for data acquisition, and coordinating validation projects.
  • Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
  • Position flows based on project needs up to and including quality approvals.
  • Undertaking any other duties for any department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

Required Skills/Experience
  • BS or higher in engineering and/or related discipline OR a minimum of 9 years relevant experience.
  • Minimum 5 years of experience in biopharmaceutical manufacturing, engineering, and/or validation
  • Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).
  • Strong knowledge of cGMP's.
  • Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.
  • Biotech and/or Sterile manufacturing and aseptic processing knowledge required.
  • Minimum of 5 years' experience in validation (with Bachelors degree) or 4 years (with a Masters degree), biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
  • Knowledge of cGMP's and Data Integrity principles.
  • Demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Good personal leadership.
  • Good communicator (written and verbal) at all levels.
  • Customer focused. Strong analytical and problem-solving ability.
  • Hands-on approach, with a 'can do' attitude. Able to work under minimal or appropriate supervision level.
  • Ability to prioritize, demonstrating good time management skills.
  • Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
  • Self-motivated, with the ability to work proactively using own initiative.
  • Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP desirable but not required.

Preferred Skills/Experience
  • Knowledgeable in Computerized System Validation (CSV) and/or Automation Validation.
  • Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP desirable but not required.

Physical Requirements:
  • Ability to work in an office environment, construction site, and laboratory or manufacturing areas.
  • May require up to 5% travel, including visits to partner or manufacturing sites.
  • Must be able to sit, stand, and use standard office equipment for extended periods.

Computer Skills:
  • Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).
  • Experience with project management tools such as Microsoft Project, Autocad, Smartsheet.
  • Familiarity with data management and visualization tools (e.g., SharePoint, Teams, Power BI).
  • Ability to create and maintain Gantt charts, dashboards, and tracking templates.
  • Comfortable working within document management systems (e.g., Veeva Vault, eQMS, or similar).

Other Qualifications: N/A
Travel: May require domestic travel up to 5% travel
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

Salary Range: $109,900.00 - $149,900.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
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About BeiGene

Sourced by ZipRecruiter

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,200 colleagues across five continents. For more information, please visit www.beigene.com .

Industry

Health care and social assistance

Company size

5,001 - 10,000 Employees

Headquarters location

Cambridge, MA, US

Year founded

2010

Social media

Twitter

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