7 дней назад
Reliability Engineer (Biopharmaceutical Manufacturing)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Reliability Engineer (Biopharmaceutical Manufacturing): Developing and maintaining reliability, predictive maintenance, and asset maintenance programs for biopharmaceutical manufacturing equipment with an accent on cGMP compliance, equipment performance evaluation, and failure prevention. Focus on root-cause analysis, reliability modeling, FMEA, FRACAS, and solving recurring equipment and plant-operation problems.
Location: Onsite in Boca Raton, Florida, United States
Company
is a biopharmaceutical company manufacturing, developing, and marketing plasma-derived products for patients at risk of infectious diseases.
What you will do
- Support maintenance reliability and predictive maintenance activities for the manufacturing facility.
- Ensure the reliability and maintainability of equipment, utilities, facilities, controls, and safety systems throughout the asset life cycle.
- Develop asset maintenance plans, preventive maintenance tasks, predictive testing programs, and risk management inputs.
- Participate in equipment specifications, supplier evaluations, commissioning, factory acceptance testing, site acceptance testing, and final installation checks.
- Analyze asset utilization, overall equipment effectiveness, remaining useful life, operating condition, reliability, and cost.
- Develop engineering solutions for recurring failures and issues affecting capacity, quality, cost, or regulatory compliance.
Requirements
- Bachelor’s degree in mechanical engineering or an equivalent discipline.
- At least 5 years of reliability engineering or maintenance experience in a cGMP pharmaceutical or biological manufacturing environment.
- Experience with process equipment such as pumps, centrifuges, refrigeration systems, and fluid-flow systems.
- Knowledge of root-cause analysis, root-cause failure analysis, FMEA, FRACAS, fault-tree analysis, Weibull analysis, reliability modeling, statistical process control, Six Sigma, and preliminary hazards analysis.
- Ability to interpret blueprints, government regulations, customer specifications, SOPs, and cGMP requirements with strong attention to detail.
- Ability to manage multiple assignments, meet deadlines, prepare data analyses and presentations, and collaborate with operations management.
Culture & Benefits
- 401(k) plan with employer match and immediate vesting.
- Medical, vision, life, dental, and pet insurance.
- Company-paid short-term and long-term disability coverage.
- Company-paid holidays and three weeks of paid time off during the first year.
- Tuition assistance after the first year.
- Free shuttle service to the Boca Tri-Rail station.
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