Manager, Process Qualification

Manager, Process Performance Qualification

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ROLE SUMMARY

Reporting to the Senior Manager, Validation & Qualification, the Manager, Process Performance Qualifications leads a team of validation engineers responsible for Process Qualification, Cleaning Validation, and Continued Process Verification (CPV) activities supporting sterile injectable manufacturing operations. The role serves as the functional expert for assigned validation programs, providing technical guidance, oversight, and coaching to direct reports and cross-functional partners to ensure compliant and effective execution of validation lifecycle activities.

The incumbent is responsible for the development, evaluation, review, approval, and maintenance of Validation Master Plans, validation protocols, reports, and associated lifecycle documentation within their area of responsibility. The role develops and applies validation standards, quality processes, and system requirements that ensure compliance with Pfizer Quality Standards, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements.

This position provides technical leadership for troubleshooting process validation and cleaning validation issues, evaluating process performance data and statistical analyses, supporting investigations and change management activities, and authoring or approving technical documentation related to manufacturing processes, products, and equipment. The Manager identifies opportunities for process improvement, implements innovative and risk-based solutions, and contributes to continuous improvement initiatives that enhance compliance, process robustness, and operational performance.

The role manages people, technological resources, and departmental priorities across multiple projects and ongoing activities of moderate complexity. Working closely with Operations, Quality, Engineering, Technical Services, and Project Management teams, the Manager supports commercial manufacturing, technology transfers, regulatory inspections, and customer audits while ensuring a state of inspection readiness within assigned validation programs. Decisions primarily impact short- to mid-term departmental objectives and require effective collaboration, influence, and communication across functional areas.

ROLE RESPONSIBILITIES

Lead, develop, and mentor a team of validation engineers responsible for Process Qualification, Cleaning Validation, and Continued Process Verification (CPV) activities supporting sterile injectable manufacturing operations.

Serve as the technical and functional expert for validation programs by providing guidance, oversight, and coaching to direct reports, cross-functional teams while building expertise across related disciplines.

Lead and manage people, technology, and financial resources for multiple validation projects and ongoing work activities of moderate complexity involving Operations, Quality, Engineering, Technical Services, and Project Management stakeholders.

Establish and maintain Validation Master Plans and validation lifecycle strategies that ensure compliance with regulatory requirements, Pfizer Quality Standards, and business objectives.

Identify opportunities for process, product, and validation program improvements and drive implementation of innovative, science-based, risk-based solutions that improve compliance, efficiency, and operational performance.

Solve moderately complex technical and operational challenges within…