4 дня назад
Senior Engineer, F&E Environmental & Contamination Control (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Engineer, F&E Environmental & Contamination Control (Biotechnology): Managing technical deviation investigations for equipment, utilities, automation, facilities, commissioning, qualification, and manufacturing support events with an accent on root cause analysis, CAPA development, technical documentation, and regulatory readiness. Focus on leading cross-functional investigations, evaluating impacts to validated systems and product quality, and applying AI-enabled analytics to improve reliability and inspection readiness.
Location: West Greenwich, Rhode Island, United States
Company
is a biotechnology company that researches, manufactures, and delivers medicines across oncology, inflammation, general medicine, and rare disease.
What you will do
- Own engineering and functional-area deviations from initiation through closure in accordance with site procedures and quality system requirements.
- Develop investigation strategies for equipment, utilities, facilities, automation, commissioning, qualification, and manufacturing support events.
- Conduct field assessments, equipment walkdowns, system reviews, and Genba activities to gather evidence and determine root causes.
- Lead root cause analysis sessions and develop technically robust corrective and preventive actions.
- Partner with Manufacturing, Quality, Automation, Maintenance, Facilities, Engineering, Process Development, and Capital Projects stakeholders.
- Support regulatory inspections, internal audits, trend analysis, reliability improvements, and inspection readiness using engineering metrics and digital tools.
Requirements
- High school diploma/GED with 10 years of relevant experience, an associate degree with 8 years, a bachelor's degree with 4 years, a master's degree with 2 years, or a doctorate.
- 5+ years of experience in pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment is preferred.
- Experience with facilities and engineering systems, equipment troubleshooting, utility systems, automation systems, and commissioning and qualification.
- Experience with DeltaV, BAS, PI, root cause analysis, change control, and quality systems is preferred.
- Strong technical writing, analytical problem-solving, and cross-functional leadership skills.
- Experience applying AI, analytics, or digital tools to investigations and continuous improvement is preferred.
Culture & Benefits
- Collaborative, innovative, and science-based work environment.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Annual bonus program, stock-based long-term incentives, and paid time off.
- Career development opportunities and flexible work models where applicable.
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