Manufacturing Operator

Job Summary The Manufacturing Operator will perform duties assigned in production areas for the manufacture and packaging of finished drug products. This role will maintain the clean rooms, packaging room and equipment used in the manufacturing of drug products. The operator will work in class 10,000 production rooms in a cGMP manufacturing area, producing drug products according to specifications and batch record requirements. The role also includes environmental monitoring, reading SOPs and work instructions, and general computer skills. This position reports to the Manufacturing Supervisor. Key Accountabilities Perform all tasks related to the manufacture and packaging of finished drug products independently. Execute and document master batch formulas and logbooks at the highest level of cGMP compliance. Complete master formulas independently to complete the training process. Participate in investigations and root cause analysis as needed. Produce monomer/cartridge, blending/pellet, and implant products. Sterilize primary packaged drug products in a steam autoclave. Perform ampule labeling operations. Perform primary packaging of drug product using only approved components. Assist in ordering production supplies and maintaining proper inventory. Follow all site safe work practices and procedures, and report unsafe acts or conditions immediately. Prepare components and supplies for primary and secondary packaging operations. Pack bulk drug products into appropriate primary container closure system. Pack drug products into appropriate secondary packaging containers/shippers. Participate in clean room and equipment maintenance. Perform environmental monitoring in clean rooms. Participate in process and cleaning validation activities as required. Qualifications High School Diploma or equivalent. Minimum 2–4 years of experience working in a cGMP manufacturing facility, preferably in a clean room environment. Minimum 2–4 years of experience operating pharmaceutical manufacturing, packaging or labeling equipment. Knowledge of cGMP regulations, SOPs, and work instructions. Knowledge of workplace health and safety requirements for hazardous substances. Ability to read/write and follow written/oral instructions. General computer skills. Skills and Abilities Teamwork and follow instructions. Good communication skills. Ability to perform machine set-up, adjustments, and operations. Ability to interact with other departments. Physical Requirements Work overtime when required. Wear respirators and other protective equipment. Wear cleanroom garments and work in class 10,000 production rooms. Work with or around hazardous substances, subject to safety restrictions. Must have 20/20 corrective vision. Compensation and Benefits The expected base pay range for this position is $52K – $63K. The position is eligible for a bonus in accordance with company programs. Bonuses are awarded at the company’s discretion. Equal Employment Opportunity Statement Keenova provides equal employment opportunities to applicants and employees without regard to race, color, gender, gender identity, sexual orientation, religions, practices and observances, national origin, pregnancy, childbirth, or related medical conditions, protected veteran status, disability, or any other category protected by law. Disclaimer The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. #J-18808-Ljbffr Mallinckrodt Pharmaceuticals