Cleanroom Technician

Cleanroom Technician - 1st Shift & 2nd Shift Openings - Sorrento Valley

The Cleanroom Technician supports daily production and packaging activities in a regulated manufacturing environment, following Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs). This role focuses on meeting production goals, performing in-process quality checks, maintaining accurate documentation in line with Good Documentation Practices (GDP), and using computerized inventory and enterprise systems to ensure timely and compliant product release.

• Perform daily production and packaging activities in accordance with GMP and all applicable SOPs.
• Consistently work toward assigned production goals and respond to unscheduled peaks in workload to ensure timely release of product and to prevent back orders.
• Collaborate with the Team Leader and production staff to understand critical raw materials, in-process procedures, and product specifications.
• Identify technical problems related to raw materials and finished products and support appropriate corrective actions.
• Conduct in-process quality checks on sub-assemblies and finished products to ensure they meet established quality standards.
• Recognize line issues and other production problems and promptly notify the Team Leader or appropriate personnel of required corrective actions.
• Maintain accurate records and documentation in accordance with GDP and related SOPs.
• Use a computerized Materials Resource Planning (MRP) system to report lot-controlled ingredients on batch records.
• Perform line clearances and document them accurately to maintain product integrity and compliance.
• Operate production machinery and equipment safely and efficiently in a cleanroom environment.
• Carry out inspection and packaging activities while adhering to quality assurance requirements.
• Close work orders accurately and in a timely manner within the appropriate systems.
• Follow all cleanroom, safety, and regulatory guidelines, including FDA, ISO, and GLP-related practices as applicable.
• Demonstrate reliability by maintaining consistent attendance and performance, helping to avoid bottlenecks in the production process.
• Be flexible to work overtime, including occasional Saturdays, based on production needs and position requirements.

• At least four years of previous assembly or packaging experience in a manufacturing environment.
• Strong understanding of standard operating procedures (SOPs), including the ability to explain what SOPs are, how they are applied in manufacturing, and provide detailed examples of following SOPs to achieve production and quality goals.
• Clear understanding of Good Documentation Practices (GDP), with the ability to explain what GDP is and describe how it was followed in previous roles.
• Hands-on experience performing line clearances, with the ability to provide accurate examples of the process.
• Experience working in a regulated medical device manufacturing or pharmaceutical environment is strongly preferred.
• Working knowledge of GMP and quality assurance practices in a manufacturing setting.
• Ability to perform machine operation, packaging, inspection, and computer-based tasks as part of production activities.
• Capability to use computerized systems, including MRP and large Enterprise Resource Planning (ERP) systems, to manage inventory and production data.
• Ability to quickly comprehend coagulation-based manufacturing processes.
• Familiarity with GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO requirements.
• Basic computer operation skills and working knowledge of Microsoft Office applications.
• Reliability and strong work ethic, with the ability to support continuous production flow and meet deadlines.
• Ability to communicate manufacturing terminology and acronyms, demonstrating comfort with manufacturing lingo.

• Previous experience in a regulated medical device or pharmaceutical manufacturing environment.
• Knowledge of qualification and validation trials is a plus.
• Experience working with SAP or similar ERP systems.
• Ability to describe machines operated and computer systems used in prior roles in detail.
• Familiari…