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8 дней назад

Engineer II, Process Engineering

74 000 - 118 400$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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.
  • Strong analytical, structured problem-solving, technical writing, communication, ownership, and time-management skills.
  • 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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