Location: Buena, NJ
The Sterile Operator will perform sterile filling and formulation equipment changeovers, operation, and sampling in accordance with approved procedures. Responsibilities include proficiency at analyzing and troubleshooting the root cause of equipment and process problems and implementing effective solutions including preventive and/or corrective maintenance repairs.
Reporting Relationships: Individual Contributor
- Demonstrate technical knowledge and experience in cleanroom operations and formulation to include aseptic filling and formulation equipment.
- Previous experience with aseptic filling in ISO 5, 7, or 8 is required.
- Responsible for all sterile area operations.
- 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 all sterile filling, formulation, and manufacturing equipment per the frequency written in the SOP.
- Operate equipment per applicable SOPs.
- Perform microbial sampling per applicable SOPs.
- Demonstrates 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.
- Other duties as assigned.
- High School Diploma or GED. Technical school preferred.
- Minimum 5 years of experience in a 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 or hear. The employee frequently is required to stand. The employee must occasionally lift and/or move up to 40 pounds. The employee is frequently required to visually inspect product and must have the ability to see clearly at close vision (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.