The Quality Engineer will be responsible for the execution of assigned activities for technical support and process validation related to new products, process, equipment, and troubleshooting of current processes associated with OTC & Cosmetic Sterile/Non-Sterile Liquids (Compounding, Filling, and Testing ) and Power Products (Blending, Capsule and Reservoir Filling of Devices). Interacts with production personnel, equipment engineering and QC Lab as well as provides some assistance and direction for less experienced engineering and technical personnel. Responsible for the execution and processing of product complaint investigations.
Execute assigned projects for the implementation of new processes, problem solving for existing processes, process optimization and process validation activities. Generate related documents including SOPs, Batch Documentation, Validation Plans, Protocols and Evaluations. Develop and execute design of experiments (DoE) to support the development and registration of manufacturing processes used to produce clinical and commercial products. Provide technical and operational support to meet customer commitments (internal and external). Support technology transfer from client or product development into the facility and, when applicable, to commercial manufacturing.
Bachelor’s degree in chemical engineering or life sciences
5+ years’ relevant experience
Direct experience with MDI and Sterile/Non-Sterile Processes
Conduct DOE’s for process development and process improvement
Ability to statistically analyze data in support of technical and regulatory documents
Knowledgeable in cGMP’s and regulatory requirements
Familiar with the activity sequence for process investigations and/or Root Cause Analysis
Knowledgeable in principles of process validation and cGMP’s
If interested in this position please send your resume to Tami Parker at firstname.lastname@example.org, or call 310.802.4415