Location: Buena, NJ
The Cleanroom Services Operator will perform cleaning and sanitization of all environmental 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.
Reporting Relationships: Individual Contributor
- Cleaning and sanitization of controlled cleanroom environments such as Equipment Preparation rooms, , and all ancillary areas. Additional responsibilities may include cleaning and sanitization of process tanks, mixers, compounding and filling equipment, product formulation processes, terminal product sterilization, finished product inspection, etc.
- Proactively identify equipment issues and perform root cause analysis, make recommendations and aid in implementation for more complex and non-reoccurring issues.
- 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, SOP’s and quality requirements.
- Interface with external vendors & service providers as/when necessary.
- Other duties as assigned by direct GL or Supervisor/Manager.
- High School Diploma or GED. Technical school preferred.
- Previous experience with cleanroom services and/or aseptic 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.
- Ability to read and understand written procedures and instructions.
- Demonstrated ability to work in a team environment.
- Excellent communication skills.
While performing the duties of this job, the employee is regularly required to:
- 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 a Full-face respirator as part of the Cleanroom 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.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.