Process Improvement Engineer

hace 2 días


Añasco, Puerto Rico Labchems Corp. A tiempo completo

Process Improvement Engineer Job Description

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Labchems Corp. is seeking a Process Improvement Engineer to drive quality excellence in our facilities and construction projects. As a key member of the Core Team, you will develop and implement quality programs, analyze data, and identify areas for improvement. Your primary responsibilities include developing technical documentation, such as Validation Protocols, Technical Investigation Reports, SOPs, Validation Plans, and Change Controls.

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Main Responsibilities:

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  • Develop and implement quality programs to meet domestic and international standards.">
  • Analyze data to identify areas for improvement and implement corrective actions.">
  • Collaborate with cross-functional teams to improve quality processes.">
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Requirements:

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We require a Bachelor's degree in Chemical, Biomedical, Mechanical, or Industrial Engineering, with 5-7 years' experience in a FDA-regulated environment. ASQ Certified Quality Engineer and/or Quality Auditor certification is preferred, along with experience in biomaterials or Lyophilization. Strong knowledge of Quality System Regulation, ISO, Design Control, and Process Validation is essential.

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Skills and Qualities:

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  • Excellent analytical and problem-solving skills.">
  • Strong communication and interpersonal skills.">
  • Ability to work collaboratively with cross-functional teams.">
  • Knowledge of Lean and Six Sigma concepts and statistical techniques.">

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