Expert Manufacturing Engineer
1170 Mark Ave Carpinteria, California 93013
Voca has an immediate opening available for a Expert Manufacturing Engineer in Carpinteria, CA! Interested candidates will reach out to Zac Roberson at firstname.lastname@example.org, direct line 952-303-8132.
This ETW is a temporary resource to help ME move forward. This is a critical engineering role responsible for cold room maintenance, water system management, contract management, vendor management, new equipment management from strategy map (small vial filler), etc. This position also maintains automated production equipment.
- Provide engineering support and process improvements to improve manufacturing efficiency, ensure product quality, and lower costs for new and existing products throughout the supply chain.
- Develop and maintain the documentation necessary, including external supplier documentation, to ensure consistent manufacture of products (processes, drawings, routings, and flow of materials throughout the supply chain).
- Define, procure and support filling, labeling and packaging automated equipment.
- Use project management skills and tools to investigate and lead projects for alternate component technologies for reduced cost or improved quality and reliability.
- Resolve equipment failures and focus actions on the root cause, assist in corrective actions, CAPAs and resolution to audit findings. Complete and support internal process validations to meet applicable FDA and regulatory requirements.
Required Education & Experience:
- Bachelor Degree in Engineering, Engineering Technology or equivalent technical Degree with 5+ years of experience or equivalent combination of education and experience.
Required Knowledge, Skills & Abilities:
- Strong interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues
- Self-Starter; Highly Organized; Complex Problem-Solving; Strong Analytical Judgment; Technical Detail-Oriented
- Prior experience in working with suppliers and/or subcontractors
- Demonstrated ability to work in a highly regulated environment
- Demonstrated business acumen
- Lean/Six Sigma manufacturing and continual process improvement experience
- Knowledge of FDA QSR requirements, ISO 13485, or other recognized international quality system standards
- Prior experience in a manufacturing engineering or technical project management discipline
- Prior experience with process/equipment validation: documentation and execution - IQ, OQ, PQ
- Experience with DI water systems, cold room management, central monitoring systems
- Experience with FMEA, DOE, SPC
- Experience with OEE, MES and CAD, SolidWorks experience preferred
- Experience with, SAP, Oracle, Agile and Electronic batch records.
- Prior experience with robotic technology, Denso and Fanuc experienced desired, Omron and Allen Bradly PLC programming
- Knowledge of Industry 4.0, AI, predictive analytics and touchless transactions