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Manufacturing Technician

Company: CorTech
Location: Oceanside
Posted on: May 3, 2021

Job Description:

Manufacturing Technician IIIDepartmentDownstream Manufacturing, OceansideJob Responsibilities The Manufacturing Technician III will largely be responsible for technical writing for the Manufacturing department, in addition to performing operations. Experience drafting Quality System documents (i.e., deviations, change managements, batch records, standard operating procedures, etc.) is required. The Manufacturing Technician III is also responsible for the operation of large and small scale chromatography columns and skids, viral filtration, ultrafiltration/diafiltration skids, bioreactors, and centrifuges, as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain said equipment. Operation and practical knowledge of glass washers, autoclaves, filters, pumps and analytical equipment to support and monitor the process is expected. Safety and Compliance are the two primary objectives of manufacturing operations. Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved. Expected duties also include planning and executing the safe and efficient operation of assigned processes, Good Documentation Practices, timely communication of deviations, incidents and/or safety concerns and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness. Involvement in planning and full execution/proper documentation of all operations associated with:o Buffer and media preparationo Upstream Productiono Protein Purification Productiono Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP)/Glasswash of misc. parts and equipmento Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes This position will be utilized by both Upstream and Downstream Manufacturing teams. Experience with DeltaV Automation Systems and Unicorn System Control or equivalent Aseptic Processing experience and knowledge required. Knowledge of quality systems, validation principles, regulatory and ICH guidelines and multi-product controls required. Background or understanding of Lean concepts (Kaizen, 5S, KanBan) desired. Works under demanding production schedules and strict compliance/quality requirements. Coordination with support groups including, but not limited to: Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, and Materials Management as a Manufacturing representative. Ability to work independently and in teams, proactive and self-managing, proven problem solving as well as a detailed and organized approach are key components to the success of this candidate. Must be flexible to work day, swing, or night shifts, and/or weekends.Knowledge, Experience, and Skills:? 0 - 4 years of relevant experience with a Bachelors degree in engineering or scientific discipline? Prior experience in a Biologics cGMP related industry is required.? Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records? Good verbal, written, and interpersonal communication skills are required? Experience with Quality systems? Working knowledge in Microsoft Office applications and administrative policies? Ability to follow direction and work under minimal supervision? Demonstrates capability in organizing more complex activities in a manufacturing processob TitleManufacturing Technician IIIDepartmentDownstream Manufacturing, OceansideJob Responsibilities The Manufacturing Technician III will largely be responsible for technical writing for the Manufacturing department, in addition to performing operations. Experience drafting Quality System documents (i.e., deviations, change managements, batch records, standard operating procedures, etc.) is required. The Manufacturing Technician III is also responsible for the operation of large and small scale chromatography columns and skids, viral filtration, ultrafiltration/diafiltration skids, bioreactors, and centrifuges, as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain said equipment. Operation and practical knowledge of glass washers, autoclaves, filters, pumps and analytical equipment to support and monitor the process is expected. Safety and Compliance are the two primary objectives of manufacturing operations. Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved. Expected duties also include planning and executing the safe and efficient operation of assigned processes, Good Documentation Practices, timely communication of deviations, incidents and/or safety concerns and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness. Involvement in planning and full execution/proper documentation of all operations associated with:o Buffer and media preparationo Upstream Productiono Protein Purification Productiono Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP)/Glasswash of misc. parts and equipmento Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes This position will be utilized by both Upstream and Downstream Manufacturing teams. Experience with DeltaV Automation Systems and Unicorn System Control or equivalent Aseptic Processing experience and knowledge required. Knowledge of quality systems, validation principles, regulatory and ICH guidelines and multi-product controls required. Background or understanding of Lean concepts (Kaizen, 5S, KanBan) desired. Works under demanding production schedules and strict compliance/quality requirements. Coordination with support groups including, but not limited to: Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, and Materials Management as a Manufacturing representative. Ability to work independently and in teams, proactive and self-managing, proven problem solving as well as a detailed and organized approach are key components to the success of this candidate. Must be flexible to work day, swing, or night shifts, and/or weekends.Knowledge, Experience, and Skills:? 0 - 4 years of relevant experience with a Bachelors degree in engineering or scientific discipline? Prior experience in a Biologics cGMP related industry is required.? Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records? Good verbal, written, and interpersonal communication skills are required? Experience with Quality systems? Working knowledge in Microsoft Office applications and administrative policies? Ability to follow direction and work under minimal supervision? Demonstrates capability in organizing more complex activities in a manufacturing processRequired Skills: Desired Skills: TransId: Organization: JobRUs.com

Keywords: CorTech, Oceanside , Manufacturing Technician, Other , Oceanside, California

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