Shire Jobs

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 The Manufacturing Technician II reports to a Process Execution Team Manufacture Supervisor on the Manufacturing floor, which supports Formulation operations. The position requires operating equipment in various controlled/non-classified and classified areas, product sampling, line clearances, data collection and completing batch record entries. In addition, the Technician will perform setup of equipment, direct product sampling activities and perform batch reconciliation and accountabilities per cGMPs. The Technician will also serve as a resource for the implementation of continuous improvement projects. Job Responsibilities Monitor process execution activities to ensure successful operations on the production floor. Typical duties include attending daily Tier 0 meetings, monitoring material and supply levels, and coordinating production tasks such as batch execution. Work collaboratively with mechanic technicians and lead technicians to resolve production-related issues such as batch set-up, execution, documentation, equipment operations, SOPs, and safety and quality inspection procedures. Perform clean in place and steam in place of process lines per SOPs. Perform, set up, and create single use connections including single use bags. Perform and execute filter integrity testing as needed per SOP. Perform parts washing of parts as necessary. Perform dispensing operations as necessary. Perform inventory control, which will require the use of SAP. Responsible for start-up, equipment operation, batch execution, material handling, cleaning, housekeeping and line clearance activities Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. Perform batch record and GMP documentation entries. Assist others to complete documentation as required. This will include mathematical computation where needed. Knowledge of light material handling equipment. Working knowledge of automated and semi-automated equipment (pumps, mixers, etc). Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls. Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Other Responsibilities Support lean activities such as performing 5S in the work area, participating in problem-solving, and process improvement analysis. Responsible for assembling, disassembling, and sanitizing various equipment. Familiarity with chemical handling and spill control procedures in connection with hazardous waste pick-up duties. Be flexible in cross training and support other work areas as needed. Assist technical staff as required with preventive maintenance procedures Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed. Education, Qualifications, Skills, and Experience Minimum Requirements Experience in a pharmaceutical production environment 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 Acquire and maintain all required certifications and qualifications for the assigned work area Good organizationa