The primary job function of this position is to provide technical support to cross-functional teams working with little or no supervision, apply project management knowledge, engineering and product/process knowledge, and ingenuity to complete projects from concept through project closure within or across disciplines.
Responsibilities:
- Lead process engineering activities in product line, including Process Validation, Cleaning Validation, Equipment Qualification (IQ/OQ/PQ), investigations to address root cause.
- Support and monitor Production as required to troubleshoot material, process and equipment problems including product loss and inefficiencies. Utilize technical abilities and experience, including the use of structured analytical techniques and technical tools such as data acquisition (manual and computerized), data analysis – especially including process capability analysis, SPC and other statistical tools.
- Provide technical evaluations and support for Engineering Change Orders and Supplier Changes including updates to specifications, drawings and procedures and required operator training.
- Design and develop equipment and processes for use in the manufacturing of products. This may include in-house design, or the use of products or components as purchased from vendors. Design, build and qualify fixtures, machines, or equipment to facilitate manufacturing capability of products.
- Support integration of new products into the manufacturing operation. Provide input to Development and Operations on materials, processing, the manufacture, and cost aspects of new products.
- Assist in the validation of new and revised manufacturing processes and equipment, ensuring compliance with all applicable company standards, procedures, and all other applicable specifications.
- Design and execute engineering studies to test hypothesis related to project outcomes.
- Applies scientific and technical knowledge to projects and responsible for timely project execution. May supervise other engineers or technicians.