Aseptic Manufacturing Technician — Cleanroom Ops, Full-time

Nivagen Pharmaceuticals Inc; Sacramento (CA); On-site; USD 58,000 - 67,000; Full time

Benefits offered by this job

Full-time Employment

Annual Bonus eligibility

Medical, Dental, and Vision coverage

PTO plan

401K plan

Job summary

Nivagen Pharmaceuticals Inc is seeking a Manufacturing Associate in Sacramento, CA to execute aseptic and cleanroom manufacturing in a cGMP environment. The role requires meticulous attention to gowning, sterile technique, and strict adherence to SOPs to protect product quality and data integrity.

You will set up and operate vial/syringe fillers, autoclaves, and isolators, follow batch records, and support media fills, validations, room qualification, CAPAs, and continuous improvement

Qualifications

• High School diploma or GED required; Associate’s or Bachelor’s degree in Life Sciences or related field preferred.
• Experience in aseptic or sterile pharmaceutical manufacturing preferred.
• Experience in cGMP-regulated environments desirable.

Responsibilities

• Perform aseptic manufacturing operations in Grade A–D cleanroom environments.
• Set up, operate, and clean equipment such as vial/syringe fillers, autoclaves, and isolators.
• Follow batch production records, SOPs, and material handling protocols.
• Support media fills, process validations, and cleanroom qualification activities.
• Participate in room and equipment sanitization and cleaning frequencies.
• Complete training and maintain qualification for aseptic operations.
• Record activities in cGMP documentation with data integrity.
• Assist with investigations, deviations, CAPAs, and continuous improvement.
• Collaborate with Quality, Validation, Engineering, and Tech Services as needed.

Skills

Aseptic technique

Cleanroom behavior

Documentation

SOPs

Team collaboration

Flexible shifts

Education

High School diploma or GED

Life sciences degree preferred

Tools

Autoclaves

Isolators

Filling equipment

Job description

Nivagen Pharmaceuticals Inc is seeking a Manufacturing Associate in Sacramento, CA to execute aseptic and cleanroom manufacturing in a cGMP environment. The role requires meticulous attention to gowning, sterile technique, and strict adherence to SOPs to protect product quality and data integrity.

You will set up and operate vial/syringe fillers, autoclaves, and isolators, follow batch records, and support media fills, validations, room qualification, CAPAs, and continuous improvement