Manufacturing Engineer II (Process Expert) (Pharmaceutical Manufacturing)

Location: Irvine, California, United States. The role supports a 24-hour pharmaceutical manufacturing operation and may require up to 50% of time on the production floor in GMP environments.

Target salary: $105,000–$120,000 per year.

Company

hirify.global is a global pharmaceutical contract development and manufacturing organization with 16 sites across three continents and more than 4,200 employees, developing and manufacturing APIs and finished dosage forms.

What you will do

• Provide technical support for GMP pharmaceutical manufacturing operations across API, formulation, aseptic fill-finish, inspection, and packaging.
• Own manufacturing documentation, including SOPs, Master Batch Records, protocols, risk assessments, investigations, and technical reports.
• Lead or support equipment qualification activities, including IQ/OQ/PQ, process validations, and continuous improvement projects.
• Manage production instrumentation through calibration, preventive maintenance, troubleshooting, requalification, and repair coordination.
• Lead investigations, root cause analyses, and corrective actions related to manufacturing events.
• Collaborate with Manufacturing, Quality, Engineering, and other stakeholders to optimize processes, introduce technologies and products, and maintain inspection readiness.

Requirements

• Bachelor’s degree in Engineering, Biological Sciences, or a related technical discipline.
• At least 3 years of experience supporting pharmaceutical, biotechnology, biologics, cell and gene therapy, or CDMO manufacturing in a GMP-regulated environment.
• Experience qualifying equipment and manufacturing processes in a regulated environment.
• Strong technical writing, data analysis, troubleshooting, problem-solving, communication, and collaboration skills.
• Working knowledge of GMP regulations, quality systems, and data integrity requirements.
• Ability to work in ISO 5–8 classified cleanrooms while wearing required gowning and PPE, and to safely lift, push, or pull materials and equipment up to 50 pounds.

Nice to have

• Experience with aseptic processing and fill-finish operations, including equipment preparation, formulation, sterile filtration, and filling.
• Experience supporting API manufacturing, sterile manufacturing, or commercial pharmaceutical production.

Culture & Benefits

• Opportunity to work across the pharmaceutical manufacturing lifecycle in a growing CDMO environment.
• Exposure to API production, aseptic fill-finish manufacturing, process validation, and cross-functional project leadership.
• Medical, dental, and vision coverage.
• Flexible Spending Account and HSA options, life insurance, disability coverage, pet insurance, and 401(k).
• Generous paid time off, sick leave, and holiday time off.