gmpvalidationprocess engineeringequipment qualificationroot cause analysiscmmschange controlcapabiomanufacturing
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Зарплата и рынок
Мало
$74к-118к/год
$91к$100кмедиана$110к
По похожим ролям (50) ~ $100к/год
На СНГ рынке: $1.4к/мес ($1.1к - $1.4к)
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В Company hidden предлагают понятную инженерную роль в значимой биотехнологической сфере, но зарплата ниже медианы рынка, а работа только на площадке и требования к статусу U.S. person заметно ограничивают доступ.
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Ниже рынкаТолько на площадкеОграничение по статусуПонятные задачиЗначимая биотехнологияХорошие льготы
Оценка от Hirify AI
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Engineer II, Process Engineering (GMP Manufacturing): Supporting and improving GMP manufacturing process equipment and capital projects at a biopharmaceutical facility with an accent on equipment reliability, product quality, and regulatory compliance. Focus on troubleshooting failure modes, executing validation and qualification activities, and managing CAPAs, change controls, and automated process updates.
Location: 100% onsite in Norwood, Massachusetts, United States. Due to U.S. export control requirements, only U.S. persons are eligible; hirify.global cannot sponsor non-U.S. persons for an export control license.
Salary: $74,000–$118,400 per year, with potential eligibility for discretionary bonus, incentive compensation, or equity.
Company
hirify.global develops mRNA technology and medicines through a biopharmaceutical manufacturing and research platform.
What you will do
Provide engineering support and subject matter expertise for GMP process equipment, including filtration, chromatography, mixing, fermentation, filling, inspection, packaging, and analytical systems.
Reduce manufacturing events, user interventions, batch record excursions, and equipment-related product impact through continuous improvement.
Own small- to medium-sized engineering projects across design, procurement, installation, commissioning, validation, and qualification.
Troubleshoot alarms, out-of-specification conditions, equipment failures, and out-of-tolerance events; determine root causes and drive resolutions.
Manage equipment assets in CMMS, including preventive maintenance, calibration data, spare parts, and work-order workflows.
Maintain quality records, turnover packages, automated methods, documentation, and audit-ready records while partnering with Quality Assurance, MS&T, Facilities, Validation, and equipment users.
Requirements
BS or MS in Chemical Engineering, Mechanical Engineering, or an equivalent discipline.
Minimum 3 years of relevant experience in Facilities, Engineering, or Operations.
Experience evaluating production performance, including OEE, MTBF, MTTF, reliability, and equipment life-cycle management.
Familiarity with Microsoft Office Suite and the ability to work with SOPs, GxP requirements, Good Documentation Practices, and data integrity standards.
Must be eligible to work as a U.S. person under applicable U.S. export control requirements.
Nice to have
Experience in a GMP manufacturing environment.
Basic statistical analysis skills.
Culture & Benefits
In-person, site-based work with direct collaboration, mentorship, and hands-on support for manufacturing operations.
Healthcare and voluntary benefit programs.
Fitness, mindfulness, and mental health resources.
Family planning support, including fertility, adoption, and surrogacy benefits.
Paid vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
Savings and investment programs plus location-specific benefits.
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