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2 часа назад

Manager, Process Performance Qualification (Pharmaceutical Manufacturing)

106 000 - 176 600$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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 hirify.global 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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