Manufacturing Engineer
BioPhase Solutions - San Diego, CA

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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.

Manufacturing Engineer

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 (MI’s)

Approve Manufacturing Routings and BOM’s, execute changes as required

Equipment status, operating condition, and operating procedures (EIN’s)

Work station layout, equipment required, access to tools, storage of tools and equipment

Material and process flow through the work areas • Process improvement activities

Process troubleshooting

Capacity Analysis

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 ECO’s for any new and existing product and processes per Document Control guidelines.

Requirements:
BS degree in an engineering discipline, preferably Mechanical, Manufacturing, or Industrial Engineering.

Two to five years’ 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 - 16 months ago - save job - - block
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