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Mechanical Engineer

2 months ago

Thousand Oaks, United States ACL Digital Full time

Title: Engineer

Location: Thousand Oaks, CA

Duration: 18 months


Preferred Qualifications

• M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry

• Excellent written and verbal communication skills

• Ability to work in a highly matrixed team environment

• 2 years of experience in the biotechnology/pharmaceutical industry

• 2 years of experience in equipment, method, and mechanical design

• Technical writing experience

• Experience with SolidWorks (or other 3D-CAD software)

• Experience with combination products and regulatory requirements

• Experience applying Minitab (or other statistical software packages)


Responsibilities:

• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and

injection devices.

• Work in teams to transfer new combination product test method and assembly

requirements to manufacturing, by developing six sigma processes and compiling

documentation for manufacturing assembly requirements.

• Develop, qualify, validate, and transfer new equipment, software, systems, and methods.

• Implement projects per Final Product Technologies and company procedures to ensure

projects are completed on schedule and within established budget.

• Provide experienced support for investigations as well as new process development

required to improve manufacturing operations.

• Coordinate test method development and delivery with selected contractors.

• Ensure that qualification parameters are met for product assembly requirements.

• Support development of cost estimates for new processes, gauges and equipment

development used in generation of capital request documentation.

• Generate procedures necessary to support department and new process equipment.

• Provide experienced training to individuals in the operation and maintenance of processes,

test methods and equipment introduced to Quality Control and/or the manufacturing

department (i.e. production operator, mechanics, process engineers).

• Participate in and assume responsibilities of team functions as assigned (i.e. Product

Improvement Teams).

• Generate/author and be responsible for the Test Method documents.

Gather test method requirements that result in equipment that operates safely and

considers ergonomic factors in the design