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Manufacturing Technician - Iii

Company: Fladger Assoc. Inc.
Location: Anaheim
Posted on: May 15, 2022

Job Description:

Job DescriptionOceanside, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities: Excellent employment opportunity for Manufacturing Technician III in the Oceanside, CA area. Local Candidates OnlyIncumbent must meet the company COVID Vaccination Requirement Prior to the Start Date.Responsible for the operation of large and small-scale chromatography columns and skids, viral filtration and ultrafiltration/diafiltration skids, as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain said equipment.Operation and practical knowledge of CIP, SIP, 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.Adhere to SOPs and cGMP regulations, with the ability to accurately complete documentation associated with clinical manufacturing.Reports to Team Lead on a regular basis online 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: Weigh, dispense, and buffer preparation.Protein purification by means of column chromatography, viral filtration and UFDF.Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP)/Glass wash of misc. parts and equipment.Proficiency and routine maintenance of analytical equipment including but not limited to pH/conductivity meters, osmometers.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.Must be flexible to workday, swing, or night shifts, and/or weekends.Experience: A minimum 3 years of relevant experience with a High School Diploma.0+ years of experience with a Bachelors Degree in Biology or related Scientific discipline.Prior experience in a Biologics cGMP related industry is preferred.Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records.Good verbal, written, and interpersonal communication skills are required.Working knowledge in Microsoft Office applications and administrative policies.Demonstrates capability in organizing more complex activities in a Manufacturing processAbility to follow direction and work under minimal supervision.by Jobble

Keywords: Fladger Assoc. Inc., Anaheim , Manufacturing Technician - Iii, Professions , Anaheim, California

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