Sterile Engineer, Specialist (On-site)

Location: On-site in Rahway, New Jersey, United States; primarily 1st shift with occasional off-shift support.

Salary: $87,300–$137,400 per year, plus potential annual bonus and long-term incentive.

Company

hirify.global develops pharmaceutical products and operates regulated research and manufacturing facilities supporting clinical, developmental, and commercial processes.

What you will do

• Provide engineering support for the FLEx Sterile 1 and Sterile 2 manufacturing areas, including quality engineering, capital projects, equipment reliability, and sterile validation.
• Support the full equipment lifecycle from commissioning through decommissioning, including installation, qualification, startup, upgrades, and lifecycle management.
• Author, execute, review, and approve qualification, validation, SOP, and technical documentation.
• Manage equipment and system changes, periodic reviews, investigations, deviations, Quality Notifications, CAPAs, and GMP asset records.
• Serve as a subject matter expert for sterilization and cleaning validation, coordinating activities with service providers and troubleshooting technical issues.
• Oversee contractors and vendors and support work orders, purchasing, budgets, asset management, regulatory inspections, and capital project administration.

Requirements

• Bachelor’s degree in engineering or science plus at least 2 years of related Drug Product, Sterile, or Validation experience.
• Strong familiarity with Quality, cGMP, Safety, and Environmental policies and procedures.
• Familiarity with sterile drug product manufacturing equipment and processes.
• Familiarity with computerized maintenance and management systems (CMMS).
• Troubleshooting ability across mechanical, electrical, and automation areas.
• Ability to adapt across Quality and Facilities responsibilities to support business needs.
• Effective organizational, communication, technical writing, and computer skills.

Nice to have

• Maintenance and engineering techniques, maintenance management, and capital project management experience.
• Independent problem-solving and the ability to lead or facilitate tasks.
• SAP Plant Maintenance experience, including gatekeeping and work order prioritization.
• Experience with eVal/Kneat, ProCal, planning and scheduling, and business or financial practices.

Culture & Benefits

• Regular employee status with medical, dental, vision, insurance, retirement, 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Visa sponsorship is not available.
• Domestic relocation is indicated; travel requirements are 10%.
• The position supports cross-functional collaboration with Operations, Quality, Engineering, Maintenance, Facilities, Global Engineering Services, OEMs, and external vendors.
• The work supports a regulated pharmaceutical manufacturing environment and the development of clinical, stability, and developmental sterile products.

Hiring process

• Applications are accepted for the United States, Canada, and Puerto Rico market site; current employees and contingent workers must use the designated internal application routes.
• Accommodation requests for the hiring process can be submitted through the company’s accommodation channel.