GMP Cleanroom Specialist

GMP Cleanroom Specialist

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 processesensuring 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 medicationswhile upholding the highest standards of excellence and ethical responsibility.

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

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.