Associate Specialist, Process Engineer (Oral Solid Dosage)

Location: Onsite in Rahway, New Jersey, United States; US and Puerto Rico residents only. Domestic relocation is indicated; travel requirements are 10%.

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

Company

hirify.global’s FLEx Center is a multi-modality drug product development and GMP clinical manufacturing facility supporting the research pipeline.

What you will do

• Lead floor-based batch manufacturing of safe, high-quality clinical supplies.
• Draft and execute GxP documentation, including batch records, equipment qualification and cleaning records, change records, and deviations.
• Support oral solid dosage processing, including blending, roller compaction, encapsulation, tableting, and related clinical manufacturing activities.
• Partner with formulators, engineers, safety representatives, and quality teams across work groups.
• Contribute to collaboration, learning, innovation, and faster development of the company’s pipeline.

Requirements

• Experience executing GxP manufacturing in a pilot plant environment.
• Experience or interest in supporting electronic batch records and MES systems.
• Knowledge and experience in drug product processing.
• Desire and willingness to learn and contribute through independent problem-solving.
• Experience leading and supporting quality investigations and change management.
• Associate’s degree in chemical engineering, Chemistry, Pharmaceutical Sciences, or a related field with at least 3 years of relevant experience, or a bachelor’s or master’s degree in one of these fields or a related scientific field.
• Ability to work with acetone and isopropyl alcohol.

Nice to have

• Knowledge of investigational drug regulatory requirements.
• Understanding of clinical supply chain operations.
• Experience with commissioning, qualification, and validation.
• Experience with spray-dried intermediates and/or hot-melt extrusion.

Culture & Benefits

• Regular employee status with medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Collaborative environment focused on inclusion, learning, innovation, and collective problem-solving.
• Flexible work arrangements are not applicable; shift is not indicated.
• No visa sponsorship is available.