Location: Buena, NJ
To provide a safe and healthy work environment for all of our employees and contractors, Teligent has mandated that all employees be fully vaccinated for COVID-19. This means that all new hires will be required to be fully vaccinated prior to their start date. We are taking this proactive step as our community continues to be negatively impacted by the pandemic and the surging Delta variant. Should you require a religious or medical accommodation, please inquire about necessary steps to secure such accommodations.
Essential Duties and Responsibilities:
The Clean Room Services Operator will perform cleaning and sanitization of all environmentally controlled areas (topical and aseptic) in accordance with approved procedures and additional tasks related to each area of the topical and/or aseptic manufacturing process. They will also be responsible for the daily functions related to the cleaning and sanitization of environmentally controlled areas.
- Coordinate the work of a group of clean room services operators in their daily functions.
- Cleaning and sanitization of controlled cleanroom environments such as equipment preparation rooms. Compounding, filling and all ancillary areas. Additional responsibilities may include cleaning and sanitization or process tanks, mixers, compounding and filling equipment, product formulation processes, terminal product sterilization, finished product inspection, etc.
- Performs operation tasks on topical and aseptic filling, formulation, and manufacturing equipment.
- Operate equipment per applicable SOPs.
- Demonstrates good behaviors related to safety, quality and production.
- Adheres to all cGMPs, compliance/regulatory mandates, SOPs and quality requirements.
- Other duties as assigned.
Education and/or Work Experience Requirements:
- High School Diploma or GED. Technical school preferred.
- Previous experience with cleanroom services and/or filling in ISO 5, 7 or 8 is preferred.
- Minimum 1 year of experience in a topical or sterile filling and manufacturing environment in pharmaceutical or medical device GMP environment.
- Demonstrated ability to work with minimal supervision and coordinate a team of 5-10 clean room services operators.
- Demonstrated ability to work in a team environment.
- Ability to read and understand written procedures and instructions.
- Excellent communication skills.
- Talk and hear.
- Stand and use cleaning and sanitization chemicals (LpH, Vesphene, Vesta-Syde, Spor-klenz, Sodium Hypochlorite solution, etc.), as part of the daily cleaning/sanitization duties.
- Must be able to wear a PAPR and full-face respirator as part of the clean room services daily duties.
- Must occasionally lift and/or move up to 40 pounds.
- Frequently required to visually inspect product and must have the ability to see clearly, (20/20 corrected vision), at close range (20 inches or less), and at a distance of 20 feet or more.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.