Process & Qualification Engineer

Process & Qualification Engineer

Our client is an independently owned and family-operated business. They market products in more than 60 countries through 12 affiliate offices plus an extensive network of agents and distributors. Innovation, ethics, quality, long-term stability, and strong relationships built with customers and partners have been the company’s key drivers since the beginning.

A recognized expert in lipid chemistry and biological extraction, the Company develops and manufactures specialty ingredients, and offer recognized formulation expertise and technological advice to the pharmaceutical and personal care industries.

They are looking for a Process & Qualification Engineer for their brand-new, state-of-the-art manufacturing facility is located in Lufkin, Texas.

Transfer of Manufacturing Processes and Technologies

  • Learn and understand oleochemical processes and related manufacturing equipment.
  • Train and support manufacturing operators, ensuring seamless technology transfer.
  • Oversee equipment bidding, vendor selection, installation, and commissioning.
  • Provide operational training and prepare for production start-ups.
  • Offer technical support during and after production start-ups.
  • Analyze test results and develop protocols for transitioning processes to full industrial scale.
  • Identify project needs, allocate resources, and monitor implementation milestones.
  • Optimize processes for reliability, efficiency, and productivity.
  • Ensure processes meet Safety, Environment, and Quality validation standards.

Validation and Qualification Activities

  • Support the execution of the Validation Plan for the new oleochemical manufacturing plant in Lufkin, TX.
  • Conduct and report Installation, Operational, and Performance Qualification (IOPQ) protocol testing.
  • Participate in Site Acceptance Tests (SATs) as needed.

Validation Master Plan Implementation

  • Apply the predefined Validation Master Plan to all systems requiring qualification or validation.
  • Perform Qualification stages, including Design, Installation, Operational, and Performance Qualification.
  • Use ENNOV document control for reviewing and approving qualification documents.
  • Coordinate Qualification activities with the Site Quality Manager to ensure compliance.

Process Equipment and Utilities

  • Assist in drafting qualification protocols and test sheets for equipment and utilities.
  • Execute qualification protocols and monitor test performance on-site.
  • Manage and resolve any discrepancies during the qualification process.
  • Review and approve qualification protocols and final reports.
  • Establish operational procedures for equipment and utilities specific to the Lufkin site.
Job Category: Engineering
Job Type: Full Time
Job Location: Lufkins (TX)

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