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Position Summary: Responsible to safely operate equipment to manufacture cell culture media and cell therapy in accordance with current Good Manufacturing Practices, including a variety of processes and packaging. Models our 4i values, integrity. Innovation, intensity, and involvement. Follows our Quality Policy by continuously improving the quality of our products & services and by ensuring global regulatory compliance. Manage materials by picking up, restocking, and ordering inventory. Experience or Proficiency with Value Streams of Packaging and Powder V Blender including weighing, Poms and Portable Fitz Mill.
Essential Functions: Commitment to Safety, by following site safety procedures and using safety equipment as required for daily tasks. Ability to document Near Miss reports, safety opportunities, accident reports, etc. Uses batch record instructions, job aids, standard operating procedures, and product specifications to complete production activities. Maintains accurate documentation, records, and logs in accordance with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and IS09000 (International Organization for Standardization). Ability to perform minor troubleshooting and problem solving in areas of set-up of equipment and processes. Ability to follow testing and inspection procedures (i.e., visual inspections, in process, final product attribute). Maintains a focus on continuous improvement helping improve equipment maintenance, safety, efficiency, and throughput. Ability to report damage to production areas and equipment, through work orders as needed. Ability to perform rework and re-packaging of materials as needed. Ability to perform specialized cleaning of manufacturing equipment in liquid and/or powder. As needed, maintain the stocking levels for gowning, consumables, cleaning products, and other manufacturing supplies. Ability to work in teams to achieve operational goals while being engaged in the process. Make effective decisions relative to position requirements and include Quality in those decisions. Presenting issues and concerns to supervisor or designee. Powder Manufacturing [Dependent on skill specialization] Ability to set-up and operate semi-manual and manual powder processing and packaging equipment. Ability to load IBCs (Bins) with raw materials (ROHs) and gross weighing's for IBCs (Bins). Ability to perform weighing processes in manual and automated powder packaging processes. Ability to perform all aspects of powder packaging, including material handling, weighing the materials, setting-up of equipment, and operating the equipment (both manual and semi-automated processes). Liquid Manufacturing [Dependent on skill specialization]. Ability to set-up and operate liquid compounding tanks and perform liquid compounding processes. Ability to set-up, operate and perform the liquid manual and automated bottle filling and packaging equipment and processes. Ability to set-up and perform the liquid bag filling and packaging process. Ability to set-up and operate sterilization processes, including autoclave sterilization, filter sterilization and Steam-ln-Place (SIP) processes. Ability to qualify in aseptic gowning techniques. Additional Information: i) Context/Environment: General - Physical and Environmental Requirements:
Work in a controlled manufacturing environment; is required to lift 25 lbs. repetitively and up to 65 pounds non-repetitively and may be required to stand for long periods of time while performing duties. able to work safely with materials and equipment. Expose to fumes and chemicals such as raw materials, cleaners, etc. able to work overtime and flexible shifts*. Various levels of gowning are required. *Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operational objectives.
iii) Essential Knowledge, Skills & Experience:
Knowledge and Experience General understanding of machinery and mechanics is required. Knowledge of computer applications and current software. High school diploma with 2 years of experience in GMP and experience with similar equipment. Technical Competencies: Experience and understanding of E1 platform SAP. Learn and demonstrate an understanding of PPI (Practical Process Improvement). Identifying and raising technical problems. Manufacturing Competencies: Quality and compliance Process knowledge Communication and risk critical issue Operational understanding Skills Strong attention to detail required. Teamwork and collaboration. Clear oral and written communication skills. Excellent Benefits Package Review our company's Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 6% Tuition Reimbursement – eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
