Senior Process Engineer

hace 2 días


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

At Qrc Group Llc, we are seeking a highly skilled Sr. Engineer to lead our efforts in designing, implementing, and improving aseptic processes and systems.

Key Responsibilities:

  • Develop and execute validation protocols (IQ/OQ/PQ) for aseptic processes and manufacturing equipment.
  • Lead investigations for deviations and CAPAs related to aseptic operations.
  • Collaborate with cross-functional teams to ensure compliance with industry standards (e.g., GMP, FDA, EMA).
  • Support FDA submissions by providing technical expertise and documentation for aseptic processing and equipment validation activities.

Requirements:

  • 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 environment.
  • Strong knowledge of aseptic processing and systems.
  • Expertise in validation methodologies (IQ/OQ/PQ) and risk management.
  • Familiarity with FDA regulations, cGMP guidelines, and industry standards.


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