Назад
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18 часов назад

Technical Operations Engineer (On-site)

87 300 - 137 400$
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
Technical Operations Engineer (Manufacturing/GMP): Supporting FLEx Non-Sterile clinical manufacturing through equipment ownership, production readiness, troubleshooting, investigations, and continuous improvement with an accent on GMP compliance, equipment reliability, and digital manufacturing systems. Focus on solving equipment and operational issues, executing engineering changes, supporting capital projects, and maintaining safe, reliable clinical supply production.

Location: On-site in Rahway, New Jersey, United States. Regular day shift; 10% travel. Relocation is not available, and visa sponsorship is not provided.

Salary: $87,300–$137,400 annually, plus eligible annual bonus and long-term incentive.

Company

hirify.global develops and manufactures pharmaceutical products and clinical supplies.

What you will do

  • Own manufacturing equipment trains or technical capability areas supporting FLEx Non-Sterile clinical manufacturing.
  • Maintain equipment readiness and provide on-floor technical support during campaigns, turnovers, changeovers, batch execution, and closeout.
  • Troubleshoot equipment, automation, and operational issues; support deviations, atypical events, root cause analysis, CAPAs, and corrective actions.
  • Author and maintain SOPs, batch and equipment instructions, risk assessments, change controls, investigations, and other GMP documentation.
  • Lead focused improvements using operational data, batch reports, alarm history, downtime information, digital manufacturing systems, and performance tracking.
  • Support capital projects, design reviews, vendor activities, FAT/SAT, commissioning, qualification, startup, equipment upgrades, and operational handover.

Requirements

  • B.S. or M.S. degree in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related discipline, with at least 3 years of relevant industrial experience.
  • Experience supporting technical work, manufacturing operations, equipment, or process improvement in a laboratory, pilot plant, pharmaceutical, biotechnology, or other regulated environment.
  • Ability to troubleshoot technical problems, organize actions, and drive issues toward resolution.
  • Ability to author and review clear technical documentation and follow controlled procedures.
  • Strong planning, prioritization, communication, and cross-functional collaboration skills.
  • Ability to work effectively in an on-site manufacturing environment and support changing operational priorities.
  • Ability to meet applicable medical screening and physical requirements for the manufacturing area.

Nice to have

  • GMP pharmaceutical or biotechnology manufacturing experience and knowledge of Good Documentation Practices.
  • Experience with oral solid dosage or specialty processes, including tablet compression, encapsulation, spray drying, film coating, blending, granulation, powder handling, containment, or device assembly.
  • Experience with equipment ownership, maintenance coordination, automation troubleshooting, investigations, CAPAs, change controls, or risk assessments.
  • Experience with capital projects, commissioning, qualification, validation, FAT/SAT, or equipment startup.
  • Experience with Lean, Six Sigma, structured problem solving, or continuous improvement methods.
  • Experience with digital manufacturing tools such as PAS-X, SAP, PI/historian systems, Power BI, data analytics platforms, or maintenance and calibration systems.
  • Experience using data to evaluate equipment performance, downtime, capacity, or recurring operational issues.

Culture & Benefits

  • Regular employee position with medical, dental, vision, insurance, retirement, 401(k), paid holidays, vacation, and sick and compassionate leave benefits.
  • Collaboration with Production, Process Engineering, Quality, Facilities, Maintenance, Automation, capital project teams, vendors, and other stakeholders.
  • Day-shift work in an on-site manufacturing environment with cross-shift handoffs and technical continuity support.
  • Inclusive workplace focused on diverse perspectives, respectful challenge, collective problem solving, safety, compliance, and continuous learning.

Hiring process

  • Applications are accepted from United States, Canada, and Puerto Rico residents through the hirify.global careers portal.
  • Current employees and contingent workers must use the designated internal application routes.

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