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В Company hidden четко описана стартовая инженерная роль с практической работой на новом стерильном производстве; при этом важно учитывать вечернюю смену, работу на месте и физические требования чистой комнаты.
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Запуск нового объекта
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Associate Specialist, Engineering - 2nd Shift (Onsite) (GMP Clinical Manufacturing): Supporting the startup and operation of a sterile clinical manufacturing facility with an accent on equipment qualification, aseptic formulation, filling, lyophilization, and GMP documentation. Focus on troubleshooting manufacturing systems, executing sterile operations, supporting investigations and change controls, and maintaining regulatory readiness.
Location: Onsite in Rahway, New Jersey, United States; 2nd shift/evening. The posting is for US and Puerto Rico residents only.
Salary: $71,900–$113,200 annual base salary, plus potential annual bonus and long-term incentive.
Company
hirify.global is developing a multi-modality drug product development and GMP clinical manufacturing facility for small molecules, biologics, and vaccines.
What you will do
Provide technical support for formulation, process development, scale-up, technology transfer, and process improvements.
Support equipment and facility design, commissioning, qualification, regulatory readiness, and operational startup activities.
Operate, monitor, clean, and troubleshoot aseptic formulation, filling, lyophilization, inspection, and related manufacturing systems.
Execute sterile manufacturing activities in formulation, component preparation, filling, lyophilization, inspection, and support areas.
Prepare and maintain investigations, change controls, corrective and preventive actions, SOPs, batch records, technical protocols, and other controlled documentation.
Support material movement, staging, inventory checks, line clearance, data review, technical assessments, and daily floor coordination.
Requirements
Bachelor’s degree in engineering, chemistry, biological sciences, pharmaceutical sciences, or another related technical discipline; candidates must be pursuing an eligible degree and preparing to graduate by July 2027, with availability to start by July 2027.
Knowledge of Good Manufacturing Practice principles and safety requirements, with the ability to learn and apply site procedures and regulatory expectations.
Strong problem-solving and organizational skills, including the ability to work independently and manage multiple priorities and deadlines.
Ability to communicate and work in partnership with others in a manufacturing environment.
Ability to prepare standard operating procedures and current GxP documents.
Excellent verbal and written communication skills.
Proficiency with Microsoft Office, equipment human-machine interfaces, SAP, and calibration and maintenance database systems.
Ability to lift up to 50 pounds, perform bending, stooping, squatting, crawling, twisting, and ladder climbing, and wear cleanroom protective gowning and respirators.
Ability to work in Grade C cleanroom conditions, complete required gowning, use personal protective equipment including a powered air-purifying respirator, maintain aseptic behaviors, and comply with safety and company procedures.
Nice to have
Internship, co-op, laboratory, pilot plant, or manufacturing experience in pharmaceutical, biotechnology, or another regulated industry.
Hands-on experience from academic or personal projects, machine-shop work, construction, equipment assembly, maintenance, fabrication, repair, or similar practical activities.
Experience working effectively in a cross-functional team.
Exposure to change control, deviation management, root cause analysis, or corrective and preventive action processes.
Technical writing or controlled-document experience.
Experience operating, setting up, disassembling, and adjusting complex equipment in sterile drug product operations, formulation, filling, lyophilization, inspection, or equipment operation.
Culture & Benefits
Regular employment with medical, dental, vision, and other insurance benefits for employees and families.
Retirement benefits including a 401(k), paid holidays, vacation, compassionate leave, and sick days.
Onsite second-shift work in a new sterile clinical manufacturing facility.
Work includes approximately 10% travel; flexible work arrangements are not applicable.
hirify.global emphasizes inclusion, collaboration, diverse perspectives, and collective problem-solving.
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