2 часа назад
Manager, Process Performance Qualification (Pharmaceutical Manufacturing)
106 000 - 176 600$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manager, Process Performance Qualification (Pharmaceutical Manufacturing): Leading process qualification, cleaning validation, and continued process verification for sterile injectable manufacturing with an accent on validation lifecycle management, cGMP compliance, and cross-functional technical leadership. Focus on solving validation and cleaning issues, analyzing process performance data, supporting investigations and regulatory inspections, and developing validation engineers.
Location: McPherson, Kansas, United States; hybrid work location assignment. Candidates must have permanent authorization to work in the United States by any employer.
Annual base salary: $106,000–$176,600, plus a 15% bonus target and eligibility for a share-based long-term incentive program.
Company
develops and manufactures pharmaceutical products, including sterile injectable medicines.
What you will do
- Lead, develop, and mentor validation engineers supporting process qualification, cleaning validation, and continued process verification for sterile injectable manufacturing.
- Own validation master plans, lifecycle strategies, protocols, reports, and related documentation.
- Provide technical leadership for investigations, deviations, CAPAs, change controls, risk assessments, and validation issues.
- Manage resources and priorities across multiple validation projects involving Operations, Quality, Engineering, Technical Services, and Project Management.
- Support commercial manufacturing, technology transfers, regulatory inspections, customer audits, and continuous inspection readiness.
- Monitor validation performance metrics and implement science-based, risk-based process improvements.
Requirements
- Bachelor’s degree with at least 4 years of relevant experience, or equivalent combinations of master’s, PhD, associate’s degree, or high school education and experience.
- Experience in pharmaceutical, biopharmaceutical, sterile manufacturing, validation, engineering, technical services, quality, or manufacturing environments.
- Experience with process validation, cleaning validation, continued process verification, validation lifecycle management, cGMP, quality systems, and regulatory expectations.
- Experience leading teams, coaching colleagues, managing performance, and influencing cross-functional decisions.
- Strong analytical, statistical, problem-solving, verbal, written, and presentation skills.
- U.S. work authorization is required; visa sponsorship is not available now or in the future.
Nice to have
- Experience leading regulatory inspections, customer audits, and remediation activities.
- Experience using AI-enabled tools such as Microsoft Copilot and other generative AI technologies with responsible AI practices.
- Experience driving process improvements, innovation, and sustainable organizational capability.
Culture & Benefits
- Hybrid work arrangement supporting a 24/7 aseptic manufacturing operation.
- Flexibility to support a two-shift, 12-hour operation when needed.
- Comprehensive health, prescription drug, dental, and vision coverage.
- 401(k) plan with matching contributions and an additional retirement savings contribution.
- Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
- Relocation assistance may be available based on business needs and eligibility.
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