Manufacturing Technician – Upstream & Downstream (cGMP / Aseptic)

Immediate need for a talented Manufacturing Technician – Upstream & Downstream (cGMP / Aseptic). This is a Fulltime opportunity with long-term potential and is located in Oceanside, CA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-03292

Pay Range: $25 - $30/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
 
Key Responsibilities:

• Manufacturing Operations
• Execute routine upstream and downstream manufacturing activities in compliance with cGMP, SOPs, and Master Batch Records
• Support aseptic processing operations and assist aseptic technicians during manufacturing runs
• Perform upstream activities including:
• Cell culture support
• Single-use systems and single-use bioreactors
• Perform downstream activities including:
• Filtration
• Filling and capping
• Lyophilizer unloading
• Packaging and pack-off operations
• Equipment & Facility Support
• Prepare equipment and components for sterilization
• Operate manufacturing and processing equipment including:
• Autoclaves
• Ovens
• Vial washers
• Depyrogenation tunnels
• Lyophilizers
• Perform Clean-In-Place (CIP) and Sterilization-In-Place (SIP) of tanks and equipment
• Clean, assemble, and disassemble manufacturing equipment
• Maintain cleanroom and manufacturing areas, including walls, ceilings, floors, and equipment
• Documentation & Systems
• Accurately complete all production documentation including:
• Batch records
• Logbooks
• Electronic and paper-based records
• Perform ERP / EMR / MES transactions (Oracle, SAP, or similar systems)
• Perform basic data calculations related to manufacturing processes
• Report deviations or variances from standard procedures to Manufacturing and Quality teams
• Operational Support
• Perform basic troubleshooting of equipment and process issues and escalate when required
• Report line performance and operational issues to the Team Lead.
• Support schedule adjustments based on manufacturing and process requirements.
• Work collaboratively with Manufacturing, Quality, Engineering, and Operations teams.

Key Requirements and Technology Experience:

• Skills-Hands-on experience in a cGMP-regulated manufacturing environment
• Strong understanding of GMP, SOPs, batch records, and GDP
• Experience supporting aseptic or sterile manufacturing operations
• Experience with upstream and/or downstream processing
• Familiarity with single-use systems and bioprocessing equipment
• Experience operating autoclaves and performing equipment cleaning
• Comfortable working with electronic and paper-based documentation
• Willingness to work flexible shifts based on production needs.
• Experience with single-use bioreactors
• Experience with ERP, EMR, or MES systems (Oracle, SAP, etc.)
• Experience with CIP/SIP
• Previous support of cell culture operations
• Ability to perform basic troubleshooting in manufacturing environments
• Prior experience in biotech, biopharma, or life sciences manufacturing

Our client is a leading Biopharmaceutical Industry and we are currently interviewing to fill this and other similar fulltime positions. If you are interested in this position, please apply online for immediate consideration.
 
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