Regulated Pharmaceutical Engineering Expert

hace 1 día


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

We are looking for an experienced Sr. Engineer to join our team at Qrc Group Llc and lead the design, implementation, and improvement of aseptic processes and systems.

Responsibilities:

  1. Design and develop aseptic processes and systems that meet regulatory requirements and industry standards.
  2. Lead cross-functional teams to ensure compliance with regulatory requirements and industry standards.
  3. Investigate and resolve issues related to aseptic operations.
  4. Support FDA submissions by providing technical expertise and documentation for aseptic processing and equipment validation activities.

Qualifications:

  • 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 environment.
  • Strong knowledge of aseptic processing and systems.
  • Expertise in validation methodologies (IQ/OQ/PQ) and risk management.


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