Manager, Process Performance Qualification

Role: Manage validation engineering for sterile injectable manufacturing, focusing on Process Qualification, Cleaning Validation, and Continued Process Verification (CPV). Objectives include ensuring compliance with cGMP, Pfizer Quality Standards, and regulatory requirements through lifecycle validation activities. Responsibilities encompass leading and mentoring validation teams, developing validation Master Plans and protocols, overseeing validation execution, troubleshooting validation issues, supporting investigations, and facilitating continuous process improvements. The role involves collaboration across Operations, Quality, Engineering, and Technical Services, supporting regulatory inspections and audits while maintaining inspection readiness. Qualifications: Bachelor's degree with at least 4 years of experience, or higher degrees with fewer years, plus expertise in pharmaceutical or biopharmaceutical sterile manufacturing, validation lifecycle management, and regulatory compliance. Preferred skills include leading regulatory inspections, driving process improvements, team leadership, and experience with AI tools. The position requires physical and mental capacity for complex data analysis, flexibility for a 24/7 aseptic environment, and limited travel. Work setup is hybrid with possible support for a two-shift schedule. The role offers a salary range of $106,000–$176,600, with bonus eligibility, relocation support, and comprehensive benefits.