One Amgen Center Drive Thousand Oaks, California 91320 | Contract
Engineer is responsible for engineering activities required for projects associated with gages and equipment for new product introduction or process transfers. Individual shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost. Phases of project include conceptualizing, specification development, purchase, design and development, manufacturing introduction, training and production support.
RESPONSIBILITIES AND AUTHORITY:
1. Implement projects per Container Science & Engineering (CSE) and company procedures to ensure projects completed on schedule and within established budget.
2. Design and assist in the design or redesign of tools and/or equipment required for manufacturing processes.
3. Investigate and develop new processes required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
4. Coordinate gage and equipment development and delivery with selected contractors.
5. Ensure that validation parameters meet product specifications, gage and equipment operation before new or changed processes or equipment introduction to the manufacturing department.
6. Support development of cost estimates for new processes, gages and equipment development used in generation of capital request documentation.
7. Maintain records of design and development activities and changes to document history as required by ISO and FDA procedures. Generate procedures necessary to support department and new product equipment.
8. Train individuals in the operation and maintenance of processes, gages and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).
9. Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). May supervise work of support staff during development and manufacture of system.
10. During all phases of CSE activities from design, through equipment acquisition, manufacture and ongoing maintenance the following requirements should be included: -
1) Work should result in equipment that operates safely and considers ergonomic factors in the design. Environmental assessment of design and resulting implementation should promote a positive impact, eliminate, or reduce negative impact.
2) Perform other duties as required by the Group Manager.
3) Comply with the requirements, responsibilities, and authority as outlined in the company operations Environmental Management Systems Manual, Quality Systems Manual, and Standard Operating Procedures.
EDUCATION AND EXPERIENCE:
- B. Sc. Degree in Engineering Mechanical preferred) or technical field with minimum of 2 years of experience in equipment development.
- Or, equivalent work experience to a minimum of 10 years’ experience in equipment development or mechanical design.
- Good communication skills.
- Individual shall have a working knowledge of computer operations.
- Individual should have an understanding of statistical techniques relating to process analysis.
- Proficient in word processing, spreadsheet analysis and general computer skills.
- Experience in the use of CAD systems for mechanical drafting and design.
- Experience in the field of medical device manufacture or Bio-Pharmaceutical is desirable. Experienced in use of analysis such as Finite Element Analysis (FEA).