7 дней назад
Manager, Process Engineering - Sterile Inspection
99 200 - 165 400$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Process Engineering - Sterile Inspection (Pharmaceutical Manufacturing): Providing technical expertise for sterile inspection operations and developing validated manufacturing processes for injectable drug products with an accent on automated inspection technologies, cGMP compliance, and equipment reliability. Focus on investigating complex deviations, leading Six Sigma improvement projects, troubleshooting automated systems, and developing junior technical colleagues.
Location: Kalamazoo, Michigan, United States; on-premise. Candidates must have permanent authorization to work in the United States. U.S. work visa sponsorship is not available. Relocation assistance may be available based on business needs and eligibility.
Annual base salary: $99,200–$165,400, plus a 12.5% bonus target and eligibility for a share-based long-term incentive program.
Company
develops and manufactures medicines and pharmaceutical products for patients worldwide.
What you will do
- Provide technical expertise and operational support for sterile inspection of injectable drug products.
- Tune visual, physical, and spectroscopy-based inspection systems and troubleshoot complex automated equipment.
- Investigate high-complexity manufacturing deviations using root-cause analysis and Six Sigma tools.
- Lead projects focused on defect reduction, equipment reliability, capacity, utilization, and cost savings.
- Develop, validate, and support technology transfer for drug product manufacturing processes.
- Prepare audit documentation, present investigations and procedures, and serve as the site inspection technology SME.
Requirements
- Bachelor’s degree with 4+ years of experience, master’s degree with 2+ years, PhD with 0+ years, associate degree with 8 years, or high school diploma with 10 years of relevant experience.
- Required experience with sterile inspection practices, processes, and equipment.
- Pharmaceutical manufacturing experience and strong technical skills in a cGMP environment.
- Ability to troubleshoot complex automated systems and support a 24-hour, 7-day operation.
- Gowning is required to access the production floor; occasional weekend or evening work and project-related travel may be required.
- Permanent U.S. work authorization is required; visa sponsorship is not available.
Nice to have
- Six Sigma Black Belt certification.
- Experience across multiple departments or functions.
- Experience with AVI recipe development on Korber Seidenader equipment.
Culture & Benefits
- Full-time employment in a pharmaceutical manufacturing environment.
- 401(k) with matching contributions and an additional retirement savings contribution.
- Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
- Medical, prescription drug, dental, and vision coverage.
- Training and technical development opportunities, including development of junior colleagues.
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