- Job Title
- Operations Technician
- Job Order ID
- Begin Date
- Winchester, KY 40391
- Other Location
Join a growing organization in Winchester, KY as an Operations Technician!
The Operations Technician is responsible for the hands-on execution of all activities in the production area. Ensures that work performed is accurate, timely, efficient and compliant with company policies, plant SOP’s, cGMP regulations, and FDA regulations. Participates in continuous improvement initiatives to improve quality, safety and/or cycle time. Collaborates effectively with other departments to ensure production goals are met.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Operation of process equipment and utilities to include changing process conditions, open/closure of valves, and sterilization of piping/tanks, monitoring process conditions and adjusting as needed.
- Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures (SOP).
- Accurately maintain proper documentation of process information.
- Maintain cGMP work environment and perform housekeeping duties as assigned.
- Add proper levels of chemicals and other additives to process as needed based on calculations or as determined.
- Report any quality deviations or non-conformances that you observe.
- Has the authority to intervene in the event of a quality or safety protocol concern.
- Monitor batch production records and documentation entries throughout the fermentation process to ensure accuracy and timely closure.
- Monitors and communicates production metrics.
- Ensures compliance with company regulatory requirement to ensure applications of cGMP compliance with respect to staff, areas, documentation, and quality requirements.
- Able to troubleshoot and resolve issues with process or equipment independently.
- Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance.
- Initiate appropriate action when process deviations occur.
- Reviews and updates SOP’s to be submitted to for final review and implementation.
- Perform on job training for new and developing operators.
- Ensure cleanliness of process areas are maintained.
Position Type/Expected Hours of Work
This is a full-time position. Must be willing to work a 12-hour shift, days or nights including weekends, holidays and overtime as required. (2 days/nights on 2 days/nights off 3 days/nights on 3 days/nights off).
Required Education and Experience
- High school diploma or GED.
- 2 years of experience in a manufacturing environment.
Preferred Education and Experience
- Bachelor’s degree in Biology, Chemistry, or Bio-Tech.
- 4-8 years of experience in a manufacturing environment.
Must be authorized to work in the United States.
This organization provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
We expressly prohibit any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of our employees to perform their job duties may result in discipline up to and including discharge.
- Required Skills
Production, sterilization, manufacturing, labor.