Teams 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.