Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Роль описана понятно и даёт серьёзную ответственность за перенос фармацевтических процессов, хотя работа с несколькими клиентскими проектами в CDMO может требовать частого переключения.
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Несколько проектовБиотехнологииПоддержка развития
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Мэтч & Сопровод
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Описание вакансии
Текст:
Hirify AI/Оригинал
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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