Manufacturing Engineer - Advanced Therapy Bioreactors

Description

This is a full time onsite role at our Bethlehem, PA facility.

Company Background: 

For over 50 years, ABEC has been a leading supplier to the biopharmaceutical manufacturing industry. ABEC’s unique value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to reduce overall cost, shorten time to market, and maximize productivity. ABEC’s products include process and equipment engineering/consulting services, comprehensive site services, and stainless steel and single use bioprocess equipment, including bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilization systems.  

Position Summary: 

The Manufacturing Engineer will support the effort to improve the methods, materials, and tooling utilized within manufacturing. This involves identifying opportunities from within the manufacturing team daily as well as executing manufacturing improvement projects based on the strategic manufacturing plan. 

Responsibilities: 

• Design custom manufacturing equipment and fixtures for mass production of single-use bioreactors. This includes sourcing electrical and mechanical hardware, designing part and assembly models in 3D CAD, and creating 2D part and assembly drawings for manufacture.
• Research, compare, and work with suppliers to purchase custom and off-the-shelf manufacturing equipment. Perform cost-benefit analysis to support expenditure for capital equipment.
• Assist in conducting supplier qualification audits to assess technical capability and productive capacity as required.
• Perform Factory Acceptance Testing (FAT) on new equipment. Write FAT test plans and troubleshoot any issues with the design or performance of the machine.
• Create Design of Experiment (DOE) test plans for optimizing process parameters and reducing cycle times.
• Lead Continuous Improvement (CI) activities at the site by actively seeking out, identifying, and executing opportunities for process improvement and cost reduction within the manufacturing process. Manage the CI process locally and participate globally in CI initiatives to drive value for the organization.
• Provide support to site personnel in the areas of Lean Manufacturing to include training, Kaizen facilitation, and determining savings associated with CI projects.
• Problem-solve process, product, and tool defects to determine root cause and resolution. 
• Improve manufacturing efficiency by analyzing and optimizing the facility layout, workflow, space requirements, and equipment layout. 
• Audit manufacturing processes and established manufacturing procedures to ensure process adherence. 
• Actively participate in company’s programs around safety and quality.
• Execute other tasks as assigned.
• Ability  to travel when required. 

Qualifications: 

• Bachelor’s degree in manufacturing engineering or industrial engineering, Mechanical Engineering or a similar technical discipline. 
• Consideration will be given to individuals who may not have the specified depth of educational background, but have extensive experience deemed to satisfy the overall requirements of the position. 
• At least (3) years’ experience in a Manufacturing Engineering role preferred, preferably involving custom-engineered technical products or equipment. 
• Experience with 3D modeling software required, with a preference for Autodesk Inventor.
• Experience with equipment validation processes (IQ, OQ, PQ) and failure mode analyses (dFMEA, pFMEA, Process Control Plans). 
• Demonstrated knowledge and application of LEAN manufacturing tools and techniques.       
• Background in biotech or chemical industry, or experience with custom-designed process equipment of a similar scale and complexity preferred. 
• Experience designing, testing, troubleshooting, and maintaining manufacturing equipment in a mass production environment. Experience with cleanroom manufacturing processes is preferred.
• Knowledge of various manufacturing processes including machining, welding, laser cutting, 3D printing, thermoforming, and injection molding.