Senior Process Development Engineer
Our client is a global leader in the processing of human bone and connective tissue. They are looking to hire a Senior Process development engineer.
PRIMARY FUNCTION:
Responsible for providing technical support to design, develop, improve and validate processes to launch new products, reduce costs, improve product quality, and reduce cycle time. Perform engineering studies for process development, write SOPs, validation protocols and reports.
DUTIES AND RESPONSIBILITIES:
-Work with scientists to understand processes and identify critical scale-up issues.
-Develop and safely execute scale-up plans to transfer processes to manufacturing.
-Work with vendors to identify and develop, if necessary, suitable equipment for new and / or improved processes. Evaluate equipment performance, including operational tests as required. These will be pre-purchase tests, either at the vendor site or with loaned equipment.
-Adopt a process ownership methodology for critical processes including utilization of techniques such as FMEA, SPC, DOE, Process Capability Analysis, engineering studies, and time and events schedules.
-Demonstrate ability to comprehensively complete required paperwork in accordance with cGMP, QSR, and SOP.
-Responsible for training technicians in transfer of product into manufacturing.
-Responsible for implementing process changes to improve quality and reduce costs. Utilize Six Sigma methodology to analyze manufacturing process capability, to identify problems and opportunities for improvement, and to develop and implement engineering solutions.
EDUCATION / EXPERIENCE:
B.S. in Chemistry, Chemical, Polymer, or Mechanical Engineering with 5+ years of experience in laboratory and pilot scale development of chemical or polymer processes, including transfer to manufacturing. M.S. degree or Ph.D. with 3-5 years of experience. Medical device experience in new product / process development would be a plus. Six SigmaTraining preferred. Must have a proven track record in developing new technology, processes, & equipment with minimal supervision.
SKILLS / ATTRIBUTES:
-Detailed understanding of and demonstrated ability to conduct validation activities (IQ/OQ/PQ).
-Knowledge of cGMP’s.
The ideal candidate should be well versed in the documentation needs required to support FDA filings.
-Demostrated proficiency in:
Statistical software (e.g. SAS JMP)
MS Windows OS, MS Office (Excel. Word, PowerPoint)
MicroSoft Project or equivalent
CAD proficient using any 3D or 2D Engineering package such as AutoCAD, ProE, or Solidworks.
Required Skills for Senior Process Development Engineer Job:
- MEDICAL DEVICE
- IQ/OQ/PQ
- AUTOCAD
- PRO-E
- SOLIDWORKS
- STATISTICAL SOFTWARE
- SPC
- SIX SIGMA DOE
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