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8 дней назад

Process Engineer III (Pharmaceutical Manufacturing)

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
Process Engineer III (Pharmaceutical Manufacturing): Leading technology transfer, process design, and scale-up for client formulation, sterile filtration, aseptic filling, and inspection/packaging programs with an accent on cGMP compliance, operational readiness, and customer-facing technical leadership. Focus on designing processes and equipment, leading quality investigations, supporting critical manufacturing runs, and transferring knowledge through commercial launch.

Location: Albuquerque, NM, United States; onsite role.

Company

hirify.global is a global contract development and manufacturing organization supporting pharmaceutical and biotech companies with development, technology transfer, and manufacturing services.

What you will do

  • Lead NPI, technology transfer, process design, and scale-up activities for formulation, sterile filtration, aseptic filling, inspection, and packaging operations.
  • Act as the functional subject matter expert across project initiation, tech transfer stage gates, commercial launch, and operational readiness.
  • Lead assessments, gap analyses, risk evaluations, readiness reviews, technical discussions, investigations, and customer-facing governance activities.
  • Generate and review batch records, engineering protocols, process flow maps, SOPs, work instructions, and other process documentation.
  • Specify and qualify process equipment, provide technical oversight during engineering and cGMP batch runs, and resolve technical execution barriers.
  • Lead deviations, root-cause investigations, CAPAs, and Change Control Requests from initiation through closure; provide training and mentorship to technical staff.

Requirements

  • Bachelor’s degree in chemical engineering, bioengineering, or a related scientific or engineering discipline.
  • Minimum of five years of engineering experience in a cGMP/FDA-regulated environment.
  • Hands-on experience with aseptic fill/finish operations, cleanroom personnel and material flows, and process design.
  • Strong working knowledge of aseptic processing technologies, including single-use strategies, sterile filtration, PUPSIT, CIP/SIP, container closure systems, and lyophilization.
  • Working knowledge of sanitary connections, valves, powder containment, and pharmaceutical process design.
  • Strong technical writing, communication, organizational, and attention-to-detail skills; ability to work independently, manage multiple tasks, and drive projects to completion.
  • Ability to read and interpret SOPs, maintain current training, follow safety requirements, and obtain and maintain gowning certification.
  • Must pass a background check and drug screen; may be required to pass Occupational Health Screening, obtain and maintain media qualification, and wear a respirator.

Culture & Benefits

  • Benefits are available from the first day of employment.
  • Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
  • 401(k) program with matching contributions.
  • Education reimbursement, learning platform, and career advancement opportunities.
  • Collaborative, safety-focused work environment with emphasis on continuous improvement and change leadership.

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