Jobs at Nivagen Pharmaceuticals, Inc.

Perform aseptic, cGMP-compliant sterile drug manufacturing in ISO cleanrooms: operate and maintain formulation, filtration, filling, autoclave and sterilization equipment; perform visual/AQL inspection, documentation, environmental monitoring, gowning, and cleaning; assist investigations, batch records, and quality activities; follow SOPs and regulatory guidelines.

Provide day-to-day technical ownership and support of PLC/HMI/SCADA and related automation systems for aseptic and packaging manufacturing. Troubleshoot, maintain, program, validate, and document automation equipment, support integrations with MES/SAP/serializations, partner with QA/Validation/IT/OT, and participate in FAT/SAT/IQ/OQ/PQ, audits, and continuous improvement to ensure GMP compliance and production uptime.

Provide technical ownership and engineering support for aseptic sterile drug-product manufacturing. Support aseptic fill/finish operations, contamination control, process validation, troubleshooting, investigations, CAPAs, change controls, technology transfer, equipment readiness, and continual process improvement within cGMP cleanroom environments while partnering with cross-functional teams.

Perform routine and specialized cleaning/sanitization of Grade A-D cleanrooms per SOPs and cGMP. Prepare disinfectants, maintain cleaning logs and Master Cleaning Schedule, don proper gowning/PPE, report anomalies, support audits, and collaborate with QA, Facilities, and Manufacturing to maintain aseptic conditions and regulatory compliance.

As a Microbiologist, you will ensure pharmaceutical products meet quality standards by conducting tests, developing methods, and maintaining compliance with regulations.

The In Process QA Associate is responsible for ensuring pharmaceutical products meet quality standards through monitoring, testing, and documentation during manufacturing, ensuring compliance with GMP and regulations.