United Spinal Association 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 www.resilience.com This position is a direct labor position on the Manufacturing floor, which supports Formulation operations. The position leads the execution of batch activities on the manufacturing floor, 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 Manufacturing Technician will perform setup of equipment, and assist with On-the-Job Training. The Mechanical Technician will also serve as a resource for the implementation of continuous improvement projects. Position Summary & Responsibilities Monitor process execution activities to ensure operations on the production floor. Act as a resource for the team. Provide support to production technicians and mechanical technicians. Help resolve production-related tasks such as batch execution and turnover activities. 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 as necessary. Perform dispensing operations as necessary. Perform inventory control and reconciliation activities, which will require the use of SAP. Perform technician tasks as required including start-up, equipment operation, batch execution, material handling, cleaning, housekeeping and line clearance activities. Manage batch records and GMP documentation on the production floor. Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Working knowledge of automated and semi-automated equipment. Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls. Support Lean Activities such as 5S in the work area. Be flexible in training and support other formulation functions and work areas as needed. Perform all other assigned duties with minimal supervision under the direction of the Process Facilitator. Minimum Qualifications Experience in a pharmaceutical, food, chemical or related 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. Preferred Qualifications High School graduate, vocation school graduate or equivalent. Working knowledge of Microsoft applications, SAP and Veeva Vault. Experience working in a Lean manufacturing environment. Knowledge of cGMPs and FDA policies/regulations. This position may also include the following conditions: This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects. Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators, gowns, gloves, face protection, other barrier equipment, etc. Moving mechanical parts, electrical current, working in high places, exposure to high heat or exposure to chemicals. Handling, managing, disposing of hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.) inclusive of exposure to bloodborne patho