GMP Cleanroom Specialist jobs in United States
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Nivagen Pharmaceuticals, Inc. · 6 hours ago

GMP Cleanroom Specialist

Nivagen Pharmaceuticals is a global pharmaceutical company committed to enhancing lives by delivering high-quality, cost-effective medications. The Cleanroom Cleaner is responsible for maintaining the cleanliness and sterility of classified manufacturing areas to support aseptic processing and regulatory compliance.

ManufacturingMarket ResearchPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

CGMP knowledgeCleanroom experienceSOP familiarityAttention to detailOrganizational skills

Required

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
Understanding of GMP, SOPs, and regulatory requirements related to clean room environments
Strong attention to detail
Excellent organizational skills
Ability to follow precise instructions
Ability to perform physically demanding tasks, including standing for extended periods, lifting, and operating cleaning equipment

Preferred

Degree in Chemistry, Microbiology, and/or experience in Sterile Cleaning and/or Aseptic Technique
Experience in cleanroom cleaning or those who have worked in a pharmaceutical manufacturing environment

Benefits

Yearly Bonus Eligible
Medical, Dental and Vision
Paid Time Off
401K Savings Plan

Company

Nivagen Pharmaceuticals, Inc.

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Nivagen is engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market.

H1B Sponsorship

Nivagen Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (19)
2023 (15)
2022 (5)
2021 (11)
2020 (7)

Funding

Current Stage
Early Stage
Total Funding
$31M
Key Investors
Telegraph Hill Partners
2026-01-06Acquired
2023-08-09Series Unknown· $5M
2020-05-19Series Unknown· $16M
Company data provided by crunchbase