Hybrid Manager, Process Qualification & CPV

Biopharma Careers; McPherson (KS); Hybrid; USD 106,000 - 177,000; Full time

Benefits offered by this job

401(k) with Pfizer matching

Retirement savings contribution

Paid vacation and holidays

Medical, dental, vision benefits

Job summary

Pfizer is seeking a Manager, Process Performance Qualifications to lead a team of validation engineers across PQ, Cleaning Validation, and CPV for sterile injectable manufacturing. You will guide technical work, oversee documentation, and ensure regulatory compliance within a dynamic, cross-functional environment.

The role requires strong leadership, expertise in validation lifecycle management, and the ability to drive continuous improvement while coordinating with Operations, Quality,

Qualifications

• Bachelor's degree with 4+ years of experience or higher credentials as listed in the job ad.
• Experience leading regulatory inspections, customer audits, and remediation activities.
• Experience in Process Validation, Cleaning Validation, CPV, and validation lifecycle management.
• Strong leadership and mentoring capabilities across cross-functional teams.

Responsibilities

• Lead and mentor validation engineers working on PQ, Cleaning Validation, and CPV for sterile injectable manufacturing.
• Serve as technical and functional expert, guiding teams and building cross-functional expertise.
• Manage resources across multiple validation projects and initiatives of moderate complexity.
• Establish Validation Master Plans and lifecycle strategies ensuring regulatory compliance.
• Identify opportunities for process improvements and implement risk-based solutions.
• Provide leadership for investigations, deviations, CAPAs, and change controls.

Skills

Leadership

Validation expertise

Cross-functional collaboration

Statistical analysis

Process qualification

Regulatory compliance

Communication

Problem solving

Education

Bachelor's degree in a relevant field

Master's degree (preferred)

Tools

Microsoft Copilot

Statistical software (e.g., Minitab)

Job description

Pfizer is seeking a Manager, Process Performance Qualifications to lead a team of validation engineers across PQ, Cleaning Validation, and CPV for sterile injectable manufacturing. You will guide technical work, oversee documentation, and ensure regulatory compliance within a dynamic, cross-functional environment.

The role requires strong leadership, expertise in validation lifecycle management, and the ability to drive continuous improvement while coordinating with Operations, Quality,