2 дня назад
Product Engineer II
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Product Engineer II (Manufacturing and Quality): Leading structured problem-solving and supporting new product introduction, validation, and qualification activities in a regulated manufacturing environment with an accent on customer issues, manufacturing deviations, and product robustness. Focus on root cause analysis, raw material change management, process capability improvement, and ECR/ECO change control.
Location: On-site in Pensacola, Florida, United States
Company
Cytiva, a operating company, develops solutions for biological research, vaccines, medicines, and cell and gene therapies.
What you will do
- Lead structured problem-solving for customer complaints, nonconformances, and manufacturing deviations.
- Identify root causes, establish containment, and implement sustainable countermeasures.
- Partner with R&D, Quality, and Manufacturing on NPI, design transfer, process characterization, and validation activities.
- Manage or support raw material changes through impact assessments, supplier evaluations, risk analysis, and validation plans.
- Analyze process and quality data to improve yield, cycle time, process capability, and product robustness.
- Drive ECR/ECO change control with appropriate documentation, risk mitigation, and cross-functional alignment.
Requirements
- Bachelor of Science in Engineering or a related technical field.
- At least 3 years of experience in product, process, or quality engineering, or product development within a regulated manufacturing environment.
- Working knowledge of manufacturing processes, preferably involving polymeric materials such as membranes, films, or nonwovens.
- Familiarity with ECO/ECR change control, raw material change management, risk assessments, and documentation in a cGMP/ISO environment.
- Strong analytical, communication, and organizational skills.
Nice to have
- Experience with NPI, including IQ/OQ/PQ validation and design transfer activities.
Culture & Benefits
- Work within 's continuous improvement system and Product Engineering Team.
- Collaborate cross-functionally with R&D, Quality, and Manufacturing.
- Benefits include health care programs and paid time off.
- Work on solutions supporting life sciences, diagnostics, biotechnology, and human health.
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