Full-Time

GMP Cleanroom Specialist

Nivagen Pharmaceuticals

Nivagen Pharmaceuticals

51-200 employees

Develops, acquires, and markets generic drugs

No salary listed

Sacramento, CA, USA

In Person

On-site in Sacramento; 1st or 2nd shift options.

Category
Biology & Biotech (1)

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Requirements
  • High school diploma or equivalent.
  • Prior experience working in a cGMP-regulated or clean room environment for a minimum of 2 years.
  • Familiarity with safety regulations and quality control processes in pharmaceutical manufacturing.
  • Knowledge: Understanding of GMP, SOPs, and regulatory requirements related to clean room environments.
  • Skills: Strong attention to detail, excellent organizational skills, and the ability to follow precise instructions.
  • Physical Requirements: Ability to perform physically demanding tasks, including standing for extended periods, lifting, and operating cleaning equipment.
Responsibilities
  • Execute cleaning and sanitization of cleanrooms classified as Grade A, B, C, and D environments, including surrounding areas such as airlocks, corridors, and material transfer zones.
  • Follow approved Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) to maintain aseptic conditions.
  • Prepare cleaning agents and disinfectant solutions (e.g., alcohol-based disinfectants, sporicidal agents) according to specifications.
  • Complete and maintain cleaning logs, checklists, and records with attention to accuracy, traceability, and data integrity.
  • Perform daily, weekly, and monthly cleaning tasks per the Master Cleaning Schedule (MCS).
  • Wear proper cleanroom gowning and Personal Protective Equipment (PPE) based on area classification and activity.
  • Ensure cleaning materials and equipment are handled and stored appropriately to prevent contamination.
  • Report any facility or equipment anomalies, contamination risks, or deviation from procedures to supervisors immediately.
  • Support internal and external audits by maintaining a high state of cleanliness and documentation readiness.
  • Collaborate with Quality Assurance, Facilities, and Manufacturing teams to uphold regulatory and safety standards.
Desired Qualifications
  • Priority will be given to applicants with experience in cleanroom cleaning or those who have worked in a pharmaceutical manufacturing environment.
Nivagen Pharmaceuticals

Nivagen Pharmaceuticals

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Nivagen Pharmaceuticals develops, acquires, and sells generic prescription drugs and OTC products for the North American market. It leverages global partnerships with FDA-approved manufacturing facilities to deliver high-quality, affordable products and collaborates with the world’s best CROs and CRAMs to develop and manufacture niche generics. The company supports small FDA-qualified manufacturers entering the U.S. market and differentiates itself through its ability to launch new generic products and its strong sales and marketing team, rather than relying on a single manufacturing or development approach. Revenue comes from product development, co-development, acquisitions, in-licensing, and providing sales and marketing services. Nivagen aims to grow its portfolio by forging CRO/CRAM partnerships, acquiring existing products, and expanding its product lineup to capture a larger share of the evolving generic and OTC market in North America.

Company Size

51-200

Company Stage

Growth Equity (Venture Capital)

Total Funding

$26M

Headquarters

Sacramento, California

Founded

2009

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Simplify Jobs

Simplify's Take

What believers are saying

  • PAI Pharma's January 6, 2026 acquisition brings Olympus-backed capital and distribution.
  • Owning the Sacramento site after February 2026 strengthens expansion and regulatory control.
  • Shortage-sensitive injectable demand supports faster commercialization for Nivagen's RTU pipeline.

What critics are saying

  • Nivagen's zinc oxide Class II recall, started October 31, 2025, remains ongoing.
  • California recalled atorvastatin tablets in September 2024 for a carbamazepine mix-up.
  • Repeated cGMP failures or sterile contamination would trigger FDA shutdowns and destroy hospital trust.

What makes Nivagen Pharmaceuticals unique

  • Sacramento's 100,000-square-foot sterile facility makes Nivagen unusually domestic for injectables.
  • Nivagen built over 20 ready-to-use sterile injectables before PAI Pharma's January 2026 acquisition.
  • Its 503B compounding and CDMO services target shortage-driven hospital demand directly.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Paid Time Off

401 (k) savings plan

Growth & Insights and Company News

Headcount

6 month growth

-4%

1 year growth

-4%

2 year growth

-7%
PE Hub
Jan 6th, 2026
Olympus-backed PAI Pharma picks up Nivagen Pharmaceuticals

Olympus-backed PAI Pharma picks up Nivagen Pharmaceuticals. Headquartered in Greenville, South Carolina, PAI is a developer, manufacturer and marketer of oral liquid medicines. * Nivagen operates an aseptic manufacturing facility in Sacramento, California, designed to support the production of IV bags, vials, prefilled syringes, and cartridges * Nivagen was founded in 2009 PAI Pharma, which is backed by Olympus Partners, has acquired Nivagen Pharmaceuticals, Inc, a Sacramento, California-based pharmaceutical company. No financial terms were disclosed. Gain instant access to our expert editorial analysis and in-depth insight. Already have an account? Sign in.

Benzinga
Jan 6th, 2026
PAI Pharma acquires Nivagen to expand US sterile injectable manufacturing amid persistent drug shortages

PAI Pharma, a portfolio company of Olympus Partners, has acquired Nivagen Pharmaceuticals, a California-based pharmaceutical company specialising in ready-to-use sterile injectables. The deal expands PAI's domestic manufacturing capabilities and addresses persistent drug shortages in the US healthcare system. Nivagen operates a state-of-the-art aseptic manufacturing facility in Sacramento, producing IV bags, vials, prefilled syringes and cartridges. The company brings over 20 injectable products to complement PAI's existing sterile portfolio of approximately 10 products in development and four on the market. The acquisition aligns with growing efforts to reshore pharmaceutical production and reduce reliance on foreign supply chains. PAI Pharma was advised by Bourne Partners, Kirkland & Ellis and KPMG, whilst Olympus Partners provided backing for the transaction.

Private Equity Info
Aug 22nd, 2022
Corbel Capital Partners invests into Nivagen Pharmaceuticals, Inc.

Corbel Capital Partners invested in Nivagen Pharmaceuticals (Sacramento, CA, US), a specialty pharmaceuticals business that develops and sells generic and branded prescription drugs.