7 дней назад
Sr. Engineer - F&E Environmental & Contamination Control (Biotechnology)
115 494 - 156 257$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Sr. Engineer - F&E Environmental & Contamination Control (Biotechnology): Investigating and resolving engineering, equipment, utility, automation, facility, commissioning, qualification, and project-related quality events with an accent on deviation ownership, root cause analysis, CAPA, and inspection-ready documentation. Focus on leading cross-functional investigations, evaluating impacts to validated systems and product quality, and using analytics and AI-enabled tools to improve reliability and compliance.
Location: West Greenwich, Rhode Island, United States
Salary: $115,494.60–$156,257.40 USD annually
Company
is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses 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.
- Investigate equipment, utility, facility, automation, commissioning, qualification, and manufacturing-support events through field assessments, system reviews, and data collection.
- Lead structured root cause analysis sessions and develop technically robust corrective and preventive actions.
- Assess impacts on validated systems, product quality, operational reliability, and regulatory compliance.
- Collaborate with Manufacturing, Quality, Automation, Maintenance, Facilities, Engineering, Process Development, Capital Projects, and Global Engineering stakeholders.
- Support regulatory inspections and audits, analyze deviation trends, and identify opportunities for systemic improvement.
Requirements
- High school diploma/GED with 10 years of related 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 other regulated manufacturing environments.
- Experience with Facilities & Engineering systems, equipment troubleshooting, utility systems, and automation systems such as DeltaV, BAS, or PI.
- Experience with commissioning and qualification, root cause analysis, change control, and quality systems.
- Strong technical writing, analytical problem-solving, and cross-functional leadership skills.
- The role is based onsite in West Greenwich, Rhode Island, United States.
Nice to have
- BS/BA in Engineering, Life Sciences, Biotechnology, Chemistry, or a related discipline.
- Experience applying AI, analytics, or digital tools to investigations and continuous improvement.
Culture & Benefits
- Collaborative, innovative, and science-based work environment.
- Comprehensive health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
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