Downstream Manufacturing Tech III Job Oceanside area,California USA,Engineering

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 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 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

Responsibilities:

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 Delta

V 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, Kan Ban) 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