US-MA, Manufacturing Technician II (2nd shift, Sun-Wed) SR0030018-MZ
Primary Role: With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. Responsibilities: 80%: This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include the following Troubleshoot and resolve process related issues Initiate and document minor deviations Execution of critical and routine production operations Perform Batch Record, Log Book and Form Prep requests Enter data in the Laboratory Information Management System (LIMS) Record data into log books Review log book data Sample preparation and testing Propose document revisions Complete required training on time Carry out work in a safe manner, notifying management of safety issues and risks 10%: This individual will manage equipment and support facility related projects by Initiating work orders Assembly and disassembly of process equipment Perform scheduled cleaning of equipment Perform standardization of equipment Support change over activities Execution of equipment and process qualifications as well as validation 10%: Staff Technical Training and Development Meet and maintain training requirements Develop and maintain personal development plan Provide annual performance self-assessment on development plan Education & Experience Requirements: Normally requires a high school diploma and 2-4 years related industry experience or an Associate s Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience. Biotech Certificate preferred Other Requirements: Prior experience in the following activities preferred: Process automation Standardization and measurements utilizing bench top equipment. (i.e. pH meter, osmometer, conductivity meter, etc.) Basic Ultra filtration knowledge Basic Cell culture knowledge Process automation
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