Aseptic Process Engineer – Sterile Fill/Finish Specialist

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Yearly bonus eligibility

Medical, dental, vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals, Inc. is seeking an experienced Aseptic Process Engineer to provide technical ownership for sterile manufacturing operations in a cGMP setting.

You will support aseptic formulation, sterile filtration, filling, stoppering, capping, sealing, inspection, and packaging for vials, syringes, cartridges, and flexible containers. Collaboration with multiple functions is essential to maintain state-of-control processes.

Qualifications

• Strong understanding of aseptic processing and sterile drug product manufacturing.
• Knowledge of contamination control and cGMP requirements.
• Experience with process validation, risk assessment, and investigation reporting.

Responsibilities

• Provide technical ownership and engineering support for sterile manufacturing operations in a cGMP environment.
• Support aseptic formulation, filling, stoppering, capping, sealing, inspection, and packaging for various formats.
• Collaborate with Manufacturing, QA, Validation, Engineering, and MSAT to ensure robust, compliant, and efficient processes.

Skills

Aseptic processing

Sterile drug product manufacturing

cGMP requirements

Contamination control

Process validation

Troubleshooting

MSAT collaboration

Education

Bachelor's degree in chemical/biochemical/biomedical engineering or related discipline

Advanced degree preferred

Job description

Nivagen Pharmaceuticals, Inc. is seeking an experienced Aseptic Process Engineer to provide technical ownership for sterile manufacturing operations in a cGMP setting.

You will support aseptic formulation, sterile filtration, filling, stoppering, capping, sealing, inspection, and packaging for vials, syringes, cartridges, and flexible containers. Collaboration with multiple functions is essential to maintain state-of-control processes.