Senior Process Engineer

hace 1 día


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

Job Overview

The Qrc Group, LLC is seeking a highly skilled and experienced Senior Process Engineer to lead efforts in the design, commissioning, implementation, and improvement of aseptic processes and systems. As an expert in aseptic processing, you will ensure high-quality production and compliance with industry standards (e.g., GMP, FDA, EMA).

Key Responsibilities

  • Lead the design, commissioning, implementation, and improvement of aseptic processes and systems.
  • Troubleshoot and resolve issues related to aseptic operations, ensuring compliance with cGMP and FDA guidelines.
  • Support FDA submissions by providing technical expertise and documentation for aseptic processing and equipment validation activities.
  • Review and prepare technical data for inclusion in regulatory submissions, ensuring compliance with FDA requirements.
  • Provide input on regulatory requirements and assist in ensuring that products meet regulatory expectations for approval.
  • Develop, execute, and document validation protocols (IQ/OQ/PQ) for aseptic processes and manufacturing equipment.
  • Lead investigations for deviations and CAPAs related to aseptic operations, ensuring timely and effective resolution.

Requirements

We are looking for a candidate with a Bachelor's or Master's Degree in Engineering, Pharmaceutical Sciences, or a related field. A minimum of 5-7 years of experience in aseptic process engineering, equipment validation, and FDA product submissions within a regulated pharmaceutical or biotech environment is required. Strong knowledge of aseptic processing and systems (e.g., filling lines, isolators, lyophilizers), as well as expertise in validation methodologies (IQ/OQ/PQ) and risk management, is essential.

Bonus Skills

  • Familiarity with FDA regulations, cGMP guidelines, and industry standards (e.g., ISO).
  • Experience with process improvement methodologies (e.g., Lean, Six Sigma).


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