BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Manufacturing Engineer to work for a leading San Diego biotechnology company.
The Manufacturing Engineer is responsible for providing engineering expertise in the areas of new product development, process development and improvement, equipment and sustaining engineering, manufacturing technologies, and project support to assure the production of World Class products. Specific Roles and Responsibilities include the following:
Integrity of Manufacturing Instructions (MIâ€™s)
Approve Manufacturing Routings and BOMâ€™s, execute changes as required
Equipment status, operating condition, and operating procedures (EINâ€™s)
Work station layout, equipment required, access to tools, storage of tools and equipment
Material and process flow through the work areas â€¢ Process improvement activities
Cross-functional communication with individuals and departments that have a stake in the manufacturing operations
Write validation protocols
Write and Execute process and equipment validations
Develop operator training protocols and assist in operator training
Develop and Implement MFG documentation for new products and processes
Communication with area manager, lead, supervisor, QE, and product improvement group
Monitoring of equipment set-ups, documentation, and operating parameters
Process yields and scrap
New Equipment acquisition
Generate equipment specifications defining machine performance criteria that are quantifiable by SPC and FEMA analysis. Develop new equipment strategies and generate documentation to support procurement of capital equipment. Develop manufacturing control plans and metrics that verify machine outputs are compliant with QSR standards. Support machine build activity through regular design reviews and milestones. Install and validate existing and new equipment, generate equipment operating instructions and conduct operator and maintenance training.
Apply engineering techniques to sustain and maximize current manufacturing efficiencies. Areas include: wet chemistry processing and filling, automated and manual assembly. Identify and implement new technologies and continuous improvement to optimize manufacturing process output. Develop and maintain Manufacturing Instructions, SPC, Routings and Bill of Materials. Perform analysis, testing and qualification as required to support raw material and part configuration changes. Identify process control points and implement appropriate process control parameters.
Generate documentation for production operations including manufacturing and equipment instructions, validation protocols, design control, pFMEA, and control plans. Maintain and generate new item information and routings per ERP requirements. Submit documents and create ECOâ€™s for any new and existing product and processes per Document Control guidelines.
BS degree in an engineering discipline, preferably Mechanical, Manufacturing, or Industrial Engineering.
Two to five yearsâ€™ experience, preferably in a pharmaceutical or medical device environment.
Prefer experience in Electrical-Mechanical Theory & Application, Process and Assembly Automation, 2D & 3D CAD, Hardware Design, Pneumatics, Instrumentation, PLC and Machine Programming, Basic Finance Theory, basic quality tools, advanced problem solving, excellent written skills.
BioPhase Solutions - 23 months ago