Manufacturing Technician II, Filling
- West Chester, OH
- $21.50-32.00 per hour
- Permanent
- Full-time
This position: The Manufacturing Technician II reports to a Process Execution Team (PET)
Supervisor/Manager on the Manufacturing floor, which supports Filling operations. This position will require working in various Controlled/Non-Classified and Classified areas. The Filling Technician
operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and completes batch record entries in accordance with cGMPsThis position may also include the following conditions:
- Perform the duties of operating assigned machinery consisting of servicing filling machines with materials, removing finished materials from machine tables, and assuring the smooth flow of product.
- Responsible for assembling, disassembling, operating and sanitizing various Filling equipment.
- Perform and execute filter integrity testing as needed per SOP
- Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
- Be able to start up and make minor adjustments to machinery
- Computer on-line may require some data input. This includes SCADA and HMI entries.
- Perform visual and physical checks of in-process and finished materials as requested.
- Work with various printing devices including printing mats.
- Perform batch record and GMP documentation entries. Maintain records and/or logs as required in the performance of job responsibilities. This will include mathematical computation where needed
- Knowledge of product security controls and material handling equipment.
- Responsible for outgoing quality leve
- Understand aseptic behaviours, media fills including line interventions, and have a basic knowledge of viable and non-viable monitoring equipment
- Perform inventory control and reconciliation activities, which may require the use of SAP in a limited role
- Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines.
- Be familiar with “Material Safety Data Sheets” for area chemicals
- Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to process facilitator.
- Assist mechanical staff with preventive maintenance procedures, as required. • Support lean activities and process improvement work such as performing 5S in the work area and Single Minute Exchange of Die (SMED), participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
- Assist with executing Validation/Engineering protocols for processes/equipment.
- Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise
- Be flexible in training and support other Filling functions as needed.
- Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.
- Acquire and maintain all required certification and qualifications for the assigned work area.
- Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Process Execution Team.
- Ability to work effectively in a team environment
- Candidate should possess the ability to work in and adapt to a changing/demanding environment.
- Some-overtime may be required with minimal advance notice to support business needs
- Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.
- Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations
- High school graduate, vocational school graduate, or equivalent.
- Prior production experience.
- Experience in a pharmaceutical or cGMP regulated environment.
- Experience working in a LEAN manufacturing environment.
- Knowledge of cGMPs and FDA policies/procedures