ASEPTIC PROCESS ENGINEER LEAD

hace 2 días


San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

**About Qrc Group, Llc**

At Qrc Group, Llc, we are committed to excellence in aseptic processing and manufacturing. Our team of experts is dedicated to delivering high-quality products that meet regulatory requirements.

As our Sr. Aseptic Process Engineer, you will lead efforts in designing, implementing, and improving aseptic processes and systems. You will be responsible for ensuring compliance with industry standards (e.g., GMP, FDA, EMA) and providing technical expertise for FDA submissions.

Key Responsibilities:

  1. Design and implement aseptic processes and systems to ensure high-quality production and compliance with industry standards
  2. Troubleshoot and resolve issues related to aseptic operations, ensuring compliance with cGMP and FDA guidelines
  3. Support FDA submissions by providing technical expertise and documentation for aseptic processing and equipment validation activities
  4. Review and prepare technical data for inclusion in regulatory submissions, ensuring compliance with FDA requirements
  5. Develop, execute, and document validation protocols (IQ/OQ/PQ) for aseptic processes and manufacturing equipment
  6. Lead investigations for deviations and CAPAs related to aseptic operations, ensuring timely and effective resolution

Requirements:

  • Bachelor's or Master's Degree in Engineering, Pharmaceutical Sciences, or a related field
  • Minimum of 5-7 years of experience in aseptic process engineering, equipment validation, and FDA product submissions within a regulated pharmaceutical or biotech environment
  • Strong knowledge of aseptic processing and systems (e.g., filling lines, isolators, lyophilizers)
  • Expertise in validation methodologies (IQ/OQ/PQ) and risk management
  • Familiarity with FDA regulations, cGMP guidelines, and industry standards (e.g., ISO)
  • Experience with process improvement methodologies (e.g., Lean, Six Sigma) is a plus


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