14 дней назад
Facilities Engineer (Medical Device Manufacturing)
69 400 - 104 200$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
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TL;DR
Facilities Engineer (Medical Device Manufacturing): Developing and executing validation protocols for facilities, utilities, HVAC, clean rooms, environmental monitoring, and cold storage in a regulated medical device manufacturing environment with an accent on cGMP compliance, qualification documentation, and cross-functional coordination. Focus on analyzing validation data, troubleshooting qualification issues, assessing change-control impacts, and improving facility validation procedures.
Location: Madison, Wisconsin, United States
Base salary: $69,400–$104,200 per year
Company
develops genomic technologies that support early disease detection, diagnosis, treatment discovery, and broader health equity.
What you will do
- Develop and execute validation plans for new and upgraded facilities and utilities.
- Prepare design specifications, qualification documentation, commissioning materials, and validation protocols.
- Validate HVAC, environmental monitoring, utilities, clean rooms, and cold-storage systems.
- Define sampling requirements and acceptance criteria using industry standards, then analyze data and prepare reports.
- Investigate qualification issues, assess change-control impacts, and maintain compliance of qualified systems.
- Coordinate schedules with cross-functional groups and vendors while leading continuous improvement initiatives.
Requirements
- At least 2 years of experience with facilities, HVAC, or utility systems in medical device or pharmaceutical manufacturing.
- At least 2 years of experience writing or executing validation activities.
- Practical understanding of FDA cGMP requirements for facilities and utilities.
- Experience with environmental monitoring and control systems, including BMS and EMS.
- Ability to manage competing projects, meet tight timelines, and collaborate across manufacturing, engineering, quality, development, and regulatory functions.
- This role is not eligible for visa sponsorship.
Nice to have
- Experience commissioning or validating a new facility.
- Experience working directly with the FDA.
Culture & Benefits
- Inclusive, collaborative environment focused on genomics innovation.
- Health, dental, and vision coverage.
- Retirement benefits and paid time off.
- Family-planning support and access to genomics sequencing.
- Eligibility for variable cash programs and, for eligible roles, equity compensation.
- Employee Resource Groups offering career development, cultural awareness, and social-responsibility opportunities.
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