Aseptic Process Engineer: Sterile Fill/Finish Specialist

Nivagen Pharmaceuticals Inc; Sacramento (CA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision

Paid time off

Yearly bonus eligibility

Benefits package

Job summary

Nivagen Pharmaceuticals Inc. is seeking an Aseptic Process Engineer to own technical processes for sterile manufacturing in a cGMP facility.

You will support formulation, sterile filtration, filling, stoppering, and packaging across vials, prefilled syringes, cartridges, and flexible containers. You will collaborate with Manufacturing, QA, Validation, Engineering, and MSAT to ensure robust, compliant operations.

Qualifications

• Bachelor’s degree in a chemical, biochemical, biomedical, or related engineering discipline.
• 3–5 years of experience in pharmaceutical or regulated manufacturing.
• Experience with aseptic processing for vials, prefilled syringes, cartridges, or bags preferred.

Responsibilities

• Provide technical support for aseptic manufacturing processes including formulation and filling.
• Serve as a technical resource during batch execution and line start-up.
• Evaluate process performance and identify opportunities to improve yield and contamination control.
• Lead or support validation activities, media fills, and technology transfer.
• Develop and implement process improvements to reduce deviations and improve efficiency.
• Author and review GMP documents and change controls.

Skills

Aseptic processing

Sterile drug manufacturing

cGMP compliance

Process troubleshooting

Data analysis

Education

Bachelor’s in Chemical/Biomedical Eng

Job description

Nivagen Pharmaceuticals Inc. is seeking an Aseptic Process Engineer to own technical processes for sterile manufacturing in a cGMP facility.

You will support formulation, sterile filtration, filling, stoppering, and packaging across vials, prefilled syringes, cartridges, and flexible containers. You will collaborate with Manufacturing, QA, Validation, Engineering, and MSAT to ensure robust, compliant operations.