Manufacturing Technician III - Filling (Dayshift)

Resilience•West Chester, OH

4d•Onsite

About The Position

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. This position report to Supervisor/Manager of Manufacturing on the Manufacturing floor, which supports Sterile operations. This position will require working in various Controlled/Non-Classified and Classified areas operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and completes batch record entries in accordance with cGMPs. This 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 level. Understand aseptic behaviors, 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 certifications 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. As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards.

Requirements

Significant experience in a pharmaceutical or cGMP regulated environment.
Ability to effectively understand, read, write, communicate, and follow instructions in the English language.
Good attention to detail.
Capability of keeping accurate records and performing mathematical calculations.
Ability to demonstrate and maintain gown qualification standards.

Nice To Haves

High school graduate, vocational school graduate or equivalent
Prior production experience
Prior Aseptic Manufacturing Experience
Experience working in a LEAN manufacturing environment
Knowledge of cGMPs and FDA policies/procedures

Responsibilities

Operate assigned machinery, including servicing filling machines with materials and removing finished materials.
Assemble, disassemble, operate, and sanitize various Filling equipment.
Perform and execute filter integrity testing as needed per SOP.
Perform cleaning and housekeeping activities for assigned areas to maintain a cGMP environment.
Start up machinery and make minor adjustments.
Perform computer on-line data input, including SCADA and HMI entries.
Perform visual and physical checks of in-process and finished materials.
Work with various printing devices.
Perform batch record and GMP documentation entries.
Maintain records and/or logs, including mathematical computation.
Utilize knowledge of product security controls and material handling equipment.
Ensure outgoing quality level.
Understand aseptic behaviors, media fills, and basic knowledge of viable and non-viable monitoring equipment.
Perform inventory control and reconciliation activities, potentially using SAP.
Perform work requirements in accordance with SOPs, cGMPs, and safety procedures.
Be familiar with Material Safety Data Sheets for area chemicals.
Be familiar with job-related safety procedures and hazards.
Report all discrepancies to the process facilitator.
Assist mechanical staff with preventive maintenance procedures.
Support lean activities and process improvement work (e.g., 5S, SMED, problem-solving).
Assist with executing Validation/Engineering protocols.
Identify and suggest process improvements while maintaining quality and cGMP compliance.
Be flexible in training and support other Filling functions.
Perform all other assigned duties with minimal supervision.
Acquire and maintain all required certifications and qualifications.
Learn new skills and develop new capabilities.
Work effectively in a team environment.
Adapt to a changing/demanding environment.
Work overtime as required with minimal advance notice.