Manufacturing Engineer in Carpinteria, CA at Volt

Date Posted: 8/16/2019

Job Snapshot

Job Description

Manufacturing Engineer-Carpinteria, CA

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.

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

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

Volt is an Equal Opportunity Employer