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Director Process Validation information

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How much do director process validation jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for director process validation in the United States is $39.54, according to ZipRecruiter salary data. Most workers in this role earn between $23.08 and $51.44 per hour, depending on experience, location, and employer.

What does a director of process validation do?

A Director of Process Validation oversees the validation of manufacturing processes to ensure products meet regulatory and quality standards. They develop validation strategies, manage teams conducting validation studies, and ensure compliance with industry regulations such as FDA or EMA guidelines. This role often involves cross-functional collaboration with quality, engineering, and operations departments to implement process improvements and address any issues that arise during production. The director also maintains documentation and supports audits and inspections related to process validation.

What are the key skills and qualifications needed to thrive as a director of process validation?

To thrive as a Director of Process Validation, you need deep expertise in process engineering, regulatory compliance, and quality assurance, typically supported by an advanced degree in science or engineering and significant experience in pharmaceutical or biotech manufacturing. Familiarity with validation protocols, statistical analysis software, and regulatory systems such as FDA, EMA, and ICH guidelines is crucial. Strong leadership, project management, and communication skills help drive cross-functional teams and ensure successful validation outcomes. These competencies are essential for maintaining product quality, regulatory approval, and operational efficiency in highly regulated environments.

What are some common challenges faced by a director of process validation, and how can they be addressed?

A Director of Process Validation often encounters challenges such as coordinating cross-functional teams, ensuring compliance with evolving regulatory requirements, and managing tight project timelines. Addressing these challenges requires strong leadership, clear communication, and a proactive approach to risk management. Building effective collaboration between quality, manufacturing, and R&D departments helps streamline validation activities and ensures robust documentation, which is critical for regulatory inspections. Staying updated on industry best practices and regulatory changes also plays a key role in maintaining successful validation programs.

What is the difference between Director Process Validation vs Process Validation Specialist?

AspectDirector Process ValidationProcess Validation Specialist
CredentialsBachelor's/Master's in Engineering, Life Sciences, or related; often with certifications like CQE or ASQ certificationsSimilar credentials; often with certifications like CQE or ASQ certifications
Work EnvironmentOversees validation teams, manages validation projects, and collaborates with multiple departmentsPerforms validation activities, executes validation protocols, and documents results
Industry UsageUsed in pharmaceutical, biotech, and medical device industries for leadership rolesCommonly used in the same industries for technical validation roles

The main difference is that the Director Process Validation holds a leadership position, overseeing validation strategies and teams, while the Process Validation Specialist focuses on executing validation tasks and protocols. Both roles require similar credentials and work within the same industry environments, but their responsibilities differ in scope and seniority.

What are popular job titles related to Director Process Validation jobs?

For Director Process Validation jobs, the most frequently searched job titles are:

Associate Director, Process Validation

San Carlos, CA • On-site

Vaxcyte
Biotechnology Research and Development • 51 - 200 employees
Learn more about Vaxcyteexternal

$174K - $203K/yr

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.

Key responsibilities

  • Lead and facilitate commercial process validation and risk management activities across manufacturing processes.

  • Support commercialization and lifecycle activities by ensuring processes remain validated and controlled.

  • Collaborate with cross-functional teams and external partners to support validation strategies and communicate validation performance and risk insights.

Job description

 Summary:

The Associate Director, Process Validation and Risk Management will lead and facilitate commercial process validation and risk management activities across Vaxcyte's end-to-end manufacturing processes. This role focuses on technical strategy, execution, and cross-functional coordination to support commercial readiness, regulatory compliance, and lifecycle management.

The incumbent will provide leadership to ensure the organization is equipped to effectively design, execute, and communicate process validation and risk management strategies to internal stakeholders, external partners, and regulatory agencies.

This position will report to the Sr. Director of Process Validation within the Global MSAT organization and will collaborate on overall validation strategy, with primary responsibility for process validation execution and risk management frameworks supporting commercial manufacturing.

Essential Functions:

Process Validation Leadership

  • Provide strategic and scientific leadership for process validation (PPQ, CPV, lifecycle validation) across commercial programs.
  • Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch.
  • Ensure alignment of validation activities with regulatory expectations and lifecycle management plans.

Risk Management

  • Develop and implement risk management frameworks, tools, and processes in collaboration with Quality.
  • Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks.
  • Monitor and communicate risk trends and key risk indicators to stakeholders.

Commercialization & Lifecycle Support

  • Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state.
  • Contribute to lifecycle management activities, including process improvements and continued process verification.

Cross-functional Interface

  • Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Engineering to support commercialization and supply continuity.
  • Partner with internal teams and external CMOs to ensure alignment on validation and risk strategies.

Technical Oversight

  • Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization.
  • Support deviation investigations, ensuring timely resolution and sustained compliance.

Regulatory

  • Contribute to authoring and reviewing regulatory filings and responses to health authorities.
  • Effectively communicate the scientific and commercial rationale for validation and risk management strategies.

Process Validation & Comparability

  • Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance.

Raw Material & Network Support

  • Provide guidance on raw material qualification strategies to ensure supply reliability.
  • Support validation activities across internal and external manufacturing networks.

Communication & Leadership

  • Communicate process validation performance and risk insights to key stakeholders.
  • Build strong working relationships and influence across a matrixed organization.
  • Contribute as a key member of the Global MSAT organization to enable successful commercialization.
  • Travel - 10-30% domestic and international travel required.  
Requirements: 
  • Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A.
  • Strong experience in biologics/vaccine manufacturing, including:
    • Process validation (PPQ/CPV)
    • MSAT, technical operations, or late-stage development
  • Technology transfer and commercialization
  • Experience in quality risk management (ICH Q9) and regulatory expectations
  • Demonstrated leadership in matrixed or cross-functional team environments
  • Ability to apply deep technical knowledge to develop strategies and drive execution
  • Strong problem-solving, organizational, and strategic planning skills
  • Excellent communication and stakeholder engagement skills
  • Ability to analyze data and align stakeholders with organizational strategy
  • Innovative and entrepreneurial mindset to drive continuous improvement
  • An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry. 

Reports to: Senior Director, Process Validation

Location: San Carlos, CA or North Carolina 

Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $174,000 - $203,000 (SF Bay Area). Salary ranges for non-California locations may vary.

 
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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013

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