Downstream Manufacturing Tech III

Oceanside, CA

Contract Duration: 7-18 months

Rate: Negotiable

Salary: NA $1.00

Responsibilities:

• Excellent employment opportunity for a Downstream Manufacturing Tech III in the Oceanside, CA area.
• Responsible for the operation of largeand 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 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:
  • 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)/Glasswash of misc. parts and equipment
  • Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes

• A minimum 3 years of relevant experience, HS Diploma and a Certificate to FETAC level 6 (GSL)
• 0 - 2 years of relevant experience with a Bachelor's 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.
• Working knowledge in Microsoft Office applications and administrative policies
• Ability to follow direction and work under minimal supervision
• Ability to work independently and in teams, proactive and self-managing.
• Demonstrates capability in organizing more complex activities in a manufacturing process
• 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
• Must be flexible to work day, swing, or night shifts, and/or weekends
• 4-10 Schedule - Start times are around 8am
• Local Candidates Only: Oceanside CA