Aseptic Process Engineer — Sterile Manufacturing Expert

Nivagen Pharmaceuticals Inc; Sacramento (CA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Yearly bonus eligibility

Medical, dental, vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals Inc. is hiring an Aseptic Process Engineer in Sacramento, CA.

This role provides technical process ownership for sterile manufacturing, supporting aseptic formulation, sterile filtration, filling, stoppering, capping, sealing, inspection, and packaging operations for vials and prefilled syringes. The successful candidate will collaborate with Manufacturing, QA, Validation, Engineering, and Maintenance to maintain robust, compliant processes and lead contamination control

Qualifications

• Bachelor’s degree in chemical/biomedical/mechanical engineering or related field.
• Experience in pharmaceutical/biotech manufacturing preferred.
• Strong knowledge of aseptic processing and validation concepts.

Responsibilities

• Provide process ownership for aseptic manufacturing and related fill/finish operations.
• Support sterile drug formats including vials and prefilled syringes.
• Lead or support investigations and CAPAs related to contamination events.
• Assist in process validation, media fills, and technology transfer.
• Ensure compliance with GMP, QA, and validation requirements.

Skills

Aseptic processing

Sterile manufacturing

cGMP compliance

Process troubleshooting

Data analysis

Education

Bachelor’s degree in chemical/biomedical/mechanical engineering or related

Advanced degree preferred

Tools

Microsoft Word

Excel

PowerPoint

Job description

Nivagen Pharmaceuticals Inc. is hiring an Aseptic Process Engineer in Sacramento, CA.

This role provides technical process ownership for sterile manufacturing, supporting aseptic formulation, sterile filtration, filling, stoppering, capping, sealing, inspection, and packaging operations for vials and prefilled syringes. The successful candidate will collaborate with Manufacturing, QA, Validation, Engineering, and Maintenance to maintain robust, compliant processes and lead contamination control