We have an immediate opening for an accomplished Process Engineer to work in the Life Sciences industry in San Diego.
Position is available immediately. Modest relocation expenses can be provided for the right candidate.
Will be responsible for:
- Implementation of process for: Formulation, fill and packaging processes to improve product quality and manufacturability and reduce cost
- Provide manufacturing support on equipment and processes as needed
- Leading the design and development of new or improved processes, equipment and products at both the system and component level to achieve quality / manufacturability / cost targets
- Design, test and implement new or improved formulation processes; Design and develop product and equipment concepts in CAD / SolidWorks independently or in conjunction with others and interface with vendors
- Design and troubleshoot components and processes using data derived from statistical and critical analyses such as DoE, LEAN, Process Capability, Root Cause Analysis, Risk Analysis/pFMEA/dFMEA
- Provide technical input for incident investigation, root cause analysis, and corrective action (CAPA/NCR)
- Work cross functionally and provide leadership for project work both internally and externally.
- BS or higher degree in Mechanical Engineering (or equivalent) with a minimum 6-8 years’ experience in a medical device (Class III preferred) or pharmaceutical company
- Process / product development within a quality system including design control in an FDA Regulated Environment
- Process and equipment validation/qualification (IQ, OQ, PQ), ability to create and interpret technical documentation & drawings
- Certification in 6-Sigma and / or Lean Manufacturing preferred
- Working knowledge of statistical sampling, sampling rationale, and statistical analysis
- Experience with SolidWorks / AutoCAD, Minitab / JMP and Microsoft Office