GMP Cleanroom Specialist

Posted 9 Days Ago
Be an Early Applicant
95834, Sacramento, CA, USA
In-Office
18-25 Hourly
Junior
Pharmaceutical
The Role
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.
Summary Generated by Built In

About the Company:

Nivagen Pharmaceuticals is a global pharmaceutical company committed to enhancing lives by delivering high-quality, cost-effective generic prescription medications and over-the-counter products across the North American market. For over a decade, we have upheld our core values of excellence, integrity, and respect for people, driving innovation and quality throughout the pharmaceutical supply chain.

Our team of dedicated professionals works collaboratively to advance manufacturing, distribution, and quality control processes—ensuring a comprehensive and modern approach to healthcare. Through vertical integration, cutting-edge technology, and a relentless pursuit of quality, we aim to redefine medication accessibility and affordability.

We invest in our employees by offering competitive pay, comprehensive benefits, and robust training and development programs. By fostering a supportive culture and prioritizing professional growth, we empower our team to innovate and make a lasting impact in the healthcare industry.

Our mission is simple yet powerful: to improve lives by providing accessible, affordable, and high-quality medications—while upholding the highest standards of excellence and ethical responsibility.

Job Location:

Nivagen Pharmaceuticals Inc.

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job: 

The Cleanroom Cleaner is responsible for performing routine and specialized cleaning of Grade A through Grade D cleanroom environments. This role ensures the cleanliness and sterility of classified manufacturing areas to support aseptic processing and regulatory compliance.

Duties and 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.

Experience and Qualifications:

  • High school diploma or equivalent. Degree in Chemistry, Microbiology, and/or experience in Sterile Cleaning and/or Aseptic Technique preferred.
  • 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.
  • Priority will be given to applicants with experience in cleanroom cleaning or those who have worked in a pharmaceutical manufacturing environment.

Knowledge, Skills, and Abilities:

  • 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.

Benefits:

  • Pay range $18-$25 per hour based on shift. 1st (6:00 am to 2:30 pm) and 2nd (2:30 pm to 10:00 pm) 
  • Yearly Bonus Eligible
  • Medical, Dental and Vision
  • Paid Time Off
  • 401K Savings Plan

Additional Information:

Nivagen affords equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Skills Required

  • High school diploma or equivalent
  • Minimum 2 years prior experience in a cGMP-regulated or clean room environment
  • Familiarity with safety regulations and quality control processes in pharmaceutical manufacturing
  • Ability to follow SOPs and cGMP requirements
  • Ability to prepare cleaning agents and disinfectant solutions to specification
  • Maintain accurate cleaning logs, checklists, and documentation with data integrity
  • Proper cleanroom gowning and PPE use
  • Physical ability to perform standing, lifting, and operate cleaning equipment
  • Degree in Chemistry or Microbiology
  • Experience in sterile cleaning and/or aseptic technique
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The Company
HQ: Sacramento, California
122 Employees
Year Founded: 2009

What We Do

Nivagen is engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market. Our vision is to deliver high quality products at affordable prices by leveraging global partnerships with the best FDA approved manufacturing facilities across the world. Our sales and marketing personnel are among the best in the world. The US generic prescription market is currently at approximately $60 billion, and over $120 billion's worth of products will be coming off of patent protection in next 10 years. Nivagen believes that, with its strategic partnership model of global alliances with highly efficient pharmaceutical companies across the globe, we can provide cost savings to the consumer while creating value for all members of the supply chain. Nivagen is focused in three areas of product development: development/co-development, acquisition/in-licensing, and providing sales and marketing services. We are actively looking to partner with CRO and CRAM to co-develop products. We are also acquiring existing products. If you are small FDA qualified manufacturer and want to launch your company or product in the US, Nivagen can provide complete turnkey solutions and cost effective delivery on an accelerated timeline.

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