Manufacturing Validation Engineer

4 weeks ago

McKinney, United States Yoh, A Day & Zimmermann Company Full time

Manufacturing Validation Engineer

Direct Hire

Location: McKinney, TX (Onsite)

Responsibilities:

  • Manage validation projects, leading all documentation in compliance with regulatory expectations. (ISO/OSHA)
  • Coordinate and oversee the execution of the validation master plan.
  • Provide support for regulatory audits, submissions, and other auditor requests.
  • Develop and execute test protocols.
  • Create commissioning, qualification, and validation documents.
  • Maintain validation documentation throughout its lifecycle.
  • Assist in validating new equipment installations.
  • Troubleshoot abnormal testing results or issues identified by colleagues.
  • Ensure accurate records of all validation activities.
  • Manage packaging performance and testing, collaborating with internal resources and suppliers.
  • Troubleshoot packaging problems, offering timely and cost-effective solutions.
  • Analyze engineering drawings and specifications for packaging requirements.
  • Collaborate with global suppliers, engineering, product management, operations, and sourcing.
  • Identify and implement cost-saving initiatives related to packaging materials and processes.
  • Optimize packaging designs for manufacturability.
  • Maintain familiarity with quality management system documentation for ISO13485 and 21CFR requirements.
  • Lead and support continuous improvement projects.
  • Support the safety committee in ensuring compliance with guidelines and regulations.
  • Act according to company Core Values and Purpose.
  • Exercise discretion and independent judgment on significant matters.
  • Manage job-related stress and meet delivery deadlines.
  • Follow OSHA and safety guidelines consistently.
  • Demonstrate teamwork and adhere to company safety standards.

Requirements:

  • Bachelor’s degree in Mechanical, Industrial, or Packaging Engineering, or equivalent.
  • Minimum of 3 years process validation experience.
  • Minimum of 1 year packaging testing experience.
  • Strong documentation skills.
  • Attention to detail and analytical thinking.
  • Ability to provide technical support and multitask effectively.
  • Fluency in English.
  • Skilled in time management and problem-solving.
  • Good administrative skills and proofreading abilities.
  • Ability to work independently and learn new tasks.
  • Physical capability to meet job demands.
  • Availability for evening/weekend work as needed.

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