Associate Engineer - GMP Technical Services
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Integrity Bio, Inc. (IBI) is a contract development and manufacturing organization, specializing in biologics formulation development and drug product manufacturing. The position is open for talented personnel who specialize in biopharmaceutical science, such as biologics manufacturing process, regulatory requirements and innovation by quality. The individual will develop and validate CGMP pharmaceutical manufacturing process including process utilities, aseptic filling, formulation, sterilization, lyophilization, and capping. The individual will actively participate in manufacturing operation.
The main responsibilities are as follows:
Validating pharmaceutical manufacturing equipment according to CGMP requirements.
Generating and executing CGMP qualification protocol.
Responsible for maintaining equipment calibrated.
Performing CGMP facility maintenance and improvement.
Developing new procedure to improve the quality of pharmaceutical manufacturing.
Executing temperature mapping using the related instruments and techniques.
Performing defined production processes according to GMP and SOP procedures.
Performing visual inspection with finished products.