Nivagen Pharmaceuticals
The Validation Engineer at Nivagen Pharmaceuticals ensures that manufacturing processes, equipment, utilities, and systems in the sterile pharmaceutical production environment meet regulatory requirements and company specifications. The role involves managing the validation lifecycle, including qualification, process validation, and documentation, while supporting cross‑functional teams to maintain compliance with cGMP, FDA, EMA, and ISO standards.
Nivagen Pharmaceuticals is a specialty pharma company engaged in developing, manufacturing, and marketing pharmaceutical products across generics, specialty drugs (including sterile injectables such as IV bags, vials, prefilled syringes, and cartridges), and 505(b)(2)s. The company operates a state-of-the-art cGMP sterile manufacturing facility in Sacramento, California, and offers end-to-end CDMO services spanning drug product development, formulation, out-licensing, and 503B compounding services for the institutional channel. Nivagen also engages in the development, acquisition, and sales of generic prescription and over-the-counter products for the North American market.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
View leadership team, funding history,
and employee contacts for Nivagen Pharmaceuticals.
12% above the average for this role