Associate Specialist, Engineering (Onsite)

Location: Onsite in Rahway, New Jersey, United States. Available to start employment by July 2027; must be able to work in Grade C cleanroom conditions, wear required gowning and powered air-purifying respirator, and perform physical tasks including lifting up to 50 pounds. Travel requirements: 10%.

Salary: $71,900–$113,200 annual base salary, plus annual bonus and long-term incentive if applicable.

Company

hirify.global is developing the FLEx Sterile 2 multi-modality drug product development and GMP clinical manufacturing facility in Rahway, New Jersey.

What you will do

• Support formulation, process development, scale-up, technology transfer, and technical operations for sterile clinical manufacturing.
• Draft and maintain investigations, change controls, standard operating procedures, batch documentation, technical protocols, and other GXP documents.
• Support equipment and facility design, commissioning, qualification, regulatory readiness, and operational startup activities.
• Operate, monitor, clean, and troubleshoot aseptic formulation, filling, lyophilization, and related manufacturing equipment.
• Execute sterile manufacturing operations, including formulation, component preparation, filling, lyophilization, inspection, material movement, staging, and line clearance.
• Contribute to deviation investigations, corrective and preventive actions, process improvements, 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.
• Knowledge of GMP 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 other employees 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 complete required gowning, wear personal protective equipment including a powered air-purifying respirator, maintain aseptic behaviors, and work in Grade C cleanroom conditions.
• Ability to follow safety and company policies and procedures and maintain a safe work environment.

Nice to have

• Internship, co-op, laboratory, pilot plant, or manufacturing experience in pharmaceutical, biotechnology, or a similarly regulated industry.
• Hands-on experience from academic or personal projects, machine-shop work, construction, equipment assembly, maintenance, fabrication, repair, or similar practical activities.
• Cross-functional teamwork experience.
• 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 full-time employment with a first-shift daytime schedule.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Work in a safe, compliant, reliable, and inclusive manufacturing environment.

Hiring process

• Employment is onsite in Rahway, New Jersey; visa sponsorship is not available.
• Selected candidates must be available to start by July 2027.