Manufacturing Technician - III Job at Fladger Assoc. Inc. in San Mateo

Responsibilities:

• Excellent employment opportunity for Manufacturing Technician III in the Oceanside, CA area. Local Candidates Only
• Incumbent 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 Bachelor's 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 process
• Ability to follow direction and work under minimal supervision.