Key Responsibilities:
- Learn manufacturing processes from various site perspectives, including Fractionation, Bulk Purification, and Fill/Finish as applicable.
- Support deviations and batch release from a process engineering perspective.
- Use worst-case data, downscale reports, etc., to draft technical assessments to justify batch release.
- Provide peer reviews for technical assessments.
- Conduct normalization calculations based on characterization testing results.
- Support ongoing taskforces for 'Right First Time' initiatives.
- May require lab or shop floor work/studies.
- Manage sample logistics for technical assessments, including sending samples to different R&D/QC departments as needed.
- Support process and equipment improvements through Global Change Control (GCC).
Minimum Requirements:
- Bachelor's Degree in Chemical, Electrical, or Mechanical Engineering.
- Familiarity with engineering design and evaluation processes.
- Basic understanding of technical product development and analysis.
- Knowledge of commonly-used engineering concepts, practices, and procedures.
- Basic knowledge of process engineering (PE) and quality control (QC) procedures.
- Familiarity with sending samples to various R&D/QC departments.