Manufacturing Technician III

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.   For more information, please visit www.resilience.com The Manufacturing Technician III is a direct labor position reporting to a Process Execution Team (PET) Process Facilitator 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 cGMPs. Job Responsibilities ·         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/WES 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.