Lead Manufacturing Technician (2nd shift)

Lead Manufacturing TechnicianThe Lead Manufacturing Technician, based in San Clemente, CA will be responsible for the completion of the scheduled production and management of preventative maintenance. The Lead will ensure proper documentation (cGMP and GDP), open/close jobs in MRP system, and provide feedback and updates to Management and Engineering. This position will also prepare components, build assemblies, and bulk drug formulations.

All activities will be performed with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality system regulation (QSR) medical device good manufacturing practices (GMP) requirements.Additional tasks will include performing the following:Filing, capping, and crimping operationsPackaging and labeling operationsSamplingVisual inspectionsDocumentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR)Track clean room, environmental chambers, and equipment preventive maintenance (PMs)To be successful in this role, you will need to have the following:Industry (medical device, pharmaceutical, and/or biotechnology) and educational experience.8 – 10 years' experience with high school diploma6 – 8 years' experience with associate degree in science or engineering4 - 6 years' experience with bachelor's degree in science or engineeringIt is highly desirable to have experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards.