Aseptic Process Engineer: Sterile Drug Manufacturing

Nivagenpharmaceuticals; Sacramento (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Nivagen Pharmaceuticals Inc. in Sacramento, CA is seeking an Aseptic Process Engineer to provide technical ownership and engineering support for sterile manufacturing in a cGMP environment.

The role covers aseptic formulation, filtration, filling, stoppering, capping, sealing, inspection, and packaging processes for vials, prefilled syringes, cartridges, and flexible containers. The candidate will collaborate across Manufacturing, Quality Assurance, Validation, Engineering, Maintenance,

Responsibilities

• Provide technical support for aseptic manufacturing processes including formulation, sterile filtration, and fill/finish operations.
• Support sterile drug product formats including vials, prefilled syringes, cartridges, and flexible containers.
• Serve as a technical resource for Manufacturing during batch execution, process setup, line start-up, changeover, and shutdown activities.
• Evaluate process performance and identify opportunities to improve robustness, yield, throughput, right-first-time execution, and contamination control.
• Support contamination control strategy implementation, including cleanroom practices, intervention management, and airflow considerations.
• Lead or support technical investigations for deviations, process excursions, contamination events, and quality issues.
• Develop, implement, and verify corrective and preventive actions related to aseptic manufacturing processes.

Job description

Nivagen Pharmaceuticals Inc. in Sacramento, CA is seeking an Aseptic Process Engineer to provide technical ownership and engineering support for sterile manufacturing in a cGMP environment.

The role covers aseptic formulation, filtration, filling, stoppering, capping, sealing, inspection, and packaging processes for vials, prefilled syringes, cartridges, and flexible containers. The candidate will collaborate across Manufacturing, Quality Assurance, Validation, Engineering, Maintenance,