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5 дней назад

Senior Equipment Process Engineer - Downstream (Biopharma)

100 500 - 145 166$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Senior Equipment Process Engineer - Downstream (Biopharma): Owns the performance, maintenance strategy, troubleshooting, modification, qualification, and lifecycle improvement of manufacturing and process equipment with an accent on reliability, compliance, and technical documentation. Focus on diagnosing complex equipment failures, designing risk-based maintenance programs, leading commissioning and qualification activities, and closing deviations, CAPAs, and change controls.

Location: Framingham, MA, United States. US and Puerto Rico residents only.

Salary: $100,500.00–$145,166.66 annually.

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines.

What you will do

  • Own the health, design basis, operating limits, criticality, documentation, maintenance strategy, and lifecycle performance of assigned manufacturing, utility, facility, or laboratory equipment.
  • Troubleshoot mechanical, electrical, instrumentation, and control-interface issues alongside mechanics and technicians through repair, testing, and return to service.
  • Develop and approve executable maintenance work packages, risk-based preventive-maintenance programs, equipment BOMs, critical-spares strategies, and obsolescence plans.
  • Lead equipment modifications and new-equipment projects, including design reviews, vendor selection, FAT/SAT, commissioning, qualification, turnover, training, and maintenance readiness.
  • Lead equipment-specific change controls and CAPAs, assess deviations, and ensure approved hardware changes are tested, documented, and closed.
  • Improve reliability by eliminating repeat failures, emergency work, avoidable downtime, and obsolete-component exposure while coordinating with Operations, Quality, Validation, Metrology, HSE, Automation, Engineering, Procurement, Stores, Finance, and vendors.

Requirements

  • Bachelor’s degree in mechanical, electrical, chemical, biomedical, or related engineering.
  • At least 3 years of engineering experience supporting manufacturing, facilities, utilities, laboratories, or complex process equipment in a regulated or high-reliability environment.
  • Demonstrated ability to troubleshoot equipment using drawings, manuals, data, failure history, and structured root-cause methods.
  • Experience developing job plans, preventive-maintenance tasks, technical specifications, spare-parts recommendations, or maintenance strategies.
  • Experience supporting equipment modifications, commissioning, qualification, change control, deviations, or CAPAs.
  • Ability to work effectively in the field and communicate technical risks and recommendations to technical teams and leaders.

Nice to have

  • Experience in biopharmaceutical, pharmaceutical, medical-device, SUT, or other cGMP manufacturing.
  • Working knowledge of CMMS/EAM systems, equipment BOMs, work-order controls, and maintenance master data.
  • Knowledge of reliability methods including criticality, FMEA, root cause analysis, condition monitoring, bad-actor elimination, and lifecycle planning.
  • Experience with P&IDs, electrical and mechanical drawings, instrumentation, controls interfaces, and OEM technical packages.
  • PE, CMRP/CRL, Lean/Six Sigma, project-management training, or related professional certification.

Culture & Benefits

  • Supportive, future-focused environment with opportunities for promotion or lateral career growth in the United States and internationally.
  • Health and wellbeing benefits, including healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave.
  • Rewards package and employee benefit programs.
  • Work contributes to medicine and vaccine delivery through digital, data, and AI-driven innovation.

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