Manager, Process Performance Qualification

About this role

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 and 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 validation programs and partner across functions to address issues impacting manufacturing, quality, and compliance objectives.

• Provide technical leadership for investigations, deviations, CAPAs, change controls, and risk assessments to ensure robust lifecycle management of validated processes and cleaning programs.

• Support regulatory inspections, customer audits, and internal assessments by representing validation programs and maintaining a state of continuous inspection readiness.

• Influence stakeholders, facilitate effective decision-making, and communicate complex technical concepts while building alignment across cross-functional teams.

• Actively share knowledge across departments, contribute to knowledge management initiatives, and strengthen technical capabilities within the organization.

• Assess talent needs, develop colleagues through coaching and mentoring, and ensure training and development programs support current and future business requirements.

• Monitor validation performance metrics, prioritize resources, and continuously improve operational effectiveness while maintaining quality and compliance standards.

  BASIC QUALIFICATIONS • Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.

PREFERRED QUALIFICATIONS • Experience leading regulatory inspections, customer audits, and remediation activities.

• Demonstrated success driving process improvements, innovation, and continuous improvement initiatives.

• Experience leading teams. Strong leadership skills with the ability to influence decisions across multiple functional areas.

• Experience developing technical talent and creating sustainable organizational capability.

• Experience using AI-enabled tools such as Microsoft Copilot and other generative AI technologies to improve productivity, support problem solving, and enhance technical documentation while applying responsible AI practices.

• Experience in pharmaceutical, biopharmaceutical, or sterile manufacturing environments within Validation, Engineering, Technical Services, Quality, or Manufacturing.

• Demonstrated people leadership experience, including coaching, development, and performance management. Experience in Process Validation, Cleaning Validation, Continued Process Verification, and validation life

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