Research and Development/Production Process Engineer

4 days ago


Shah Alam, Selangor, Malaysia Hiredly X Full time

This job is about ensuring that our production processes run smoothly and efficiently. You might like this job because it involves problem-solving, improving manufacturing, and working on new products to boost production capacity.

Responsibilities
  • Take on full responsibility for the coordination and management of all equipment and process IQ's, OQ's and PQ's
  • Monitor and improve BIOVIC's manufacturing processes with respect to yield and throughput
  • Coordinate and manage all production process validations
  • Coordinate and manage process validations of new products and line extensions
  • Assist with increasing production capacity by streamlining and wherever possible automating manufacturing processes
  • Keep all process FMEAs up to date
Job Requirements
  • Candidate must have at a minimum a bachelor's degree in an engineering or science discipline
  • At least 4-5 years' work experience in this field required; medical device background preferred
  • Experience with ISO 13485 quality system is required, product/process FMEA will be a plus
  • Must be able to understand and familiarize oneself with company's multi-step manufacturing process (training will be provided).
  • Must be familiar with writing and performing equipment and process IQ's, OQ's and PQ's
  • Must be familiar with writing and running process validations
  • Must be comfortable with basic statistics and statistical software, familiarity with Design of Experiments is preferred
  • Must demonstrate proficiency with following SOP's, and must have good attention to detail.
  • All protocols and reports must be in English, as such excellent spoken & written English skills are required.
  • A diverse skillset is preferred as we work as a team, and may need to assist other departments
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