Sr. Manager, Validations
$139,100–$231,900 year
Hybrid · McPherson, Kansas, United States
Job Summary
Lead site validation and qualification programs across aseptic manufacturing, including Process Validation, Cleaning Validation, Aseptic Process Simulations (APS/media fills), Equipment/Utility/Facility qualifications, and Smoke Studies; serve as site SME for validation with regulatory interactions during FDA/global inspections; build and lead a large, diverse team of validation engineers and managers; develop and govern robust validation lifecycle strategies aligned with PQS, regulatory requirements, and industry best practices; provide governance for capital projects and changes requiring qualification; ensure data integrity and lifecycle management to sustain inspection readiness; collaborate with Operations, Engineering, Technical Services, Quality Compliance, Regulatory Affairs, and Automation; communicate effectively to senior leadership and regulators; support 24/7 aseptic manufacturing with a hybrid work arrangement.
Required Qualifications
- Bachelor's degree and 6+ years of relevant experience OR Master's degree and 5+ years OR PhD with 1+ years; strong GMP validation/qualification expertise in aseptic pharmaceutical manufacturing; extensive experience in aseptic processing validation including APS/media fills, sterilization, and critical utility systems; knowledge of pharmaceutical quality systems (deviations, investigations, change control, CAPA, documentation); minimum 7+ years in pharmaceutical/biotech manufacturing; experience in aseptic cGMP manufacturing and validation lifecycle management; preferred: Six Sigma/continuous improvement; strong leadership, cross-functional governance, regulatory interactions, and inspection support
Additional Requirements
- US work authorization required; Pfizer-specific: U.S. work visa sponsorship is not available for this role now or in the future; relocation may be available based on business needs; candidates must be authorized to be employed in the United States by any employer.
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