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17 часов назад

Quality Associate Engineer III (Pharmaceutical Manufacturing)

96 000 - 132 000$
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
Quality Associate Engineer III (Pharmaceutical Manufacturing): Leading quality engineering initiatives, validation activities, and process improvement projects for sterile pharmaceutical products with an accent on visual inspection modernization, regulatory compliance, and scientific methodology development. Focus on solving manufacturing non-conformances, designing experiments, writing validations and procedures, and maintaining FDA- and ISO-compliant operations.

Location: Round Lake, Illinois, United States. Applicants must be authorized to work for any employer in the U.S.

Salary: $96,000–$132,000 annually, plus potential discretionary bonuses.

Company

hirify.global develops healthcare products and solutions focused on saving and sustaining lives.

What you will do

  • Lead quality engineering activities and daily departmental work for assigned areas.
  • Drive root-cause analysis and problem solving for manufacturing non-conformances.
  • Lead process and product improvement projects, design of experiments, validations, methodology development, data generation, and technical reporting.
  • Write, review, analyze, and revise procedures to meet corporate, plant, divisional, and regulatory requirements.
  • Partner with functions, facilities, divisions, and regions to implement procedures and maintain compliance.
  • Lead audit-readiness efforts and support audits, assessments, and validation activities as a subject matter expert.

Requirements

  • Bachelor’s degree in science or engineering.
  • At least 5 years of experience in IT, engineering, science, or a related field.
  • Working knowledge of FDA regulations, Good Laboratory Practices, and Good Manufacturing Practices.
  • Strong technical writing, analytical, technical, problem-solving, communication, influencing, and negotiation skills.
  • Ability to develop scientific strategies and create new methods or investigation approaches.
  • Good project management skills.

Culture & Benefits

  • Mission-driven environment focused on saving and sustaining lives.
  • Medical and dental coverage beginning on the first day for eligible employees.
  • Life, disability, business travel accident, and other insurance coverage.
  • 401(k) retirement plan with employee contributions and company matching, plus an employee stock purchase plan.
  • Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
  • Educational assistance, flexible spending accounts, commuting benefits, childcare benefits, and employee assistance programs.

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