- Characterization Process Development Specialist
Technical Requirements
- Equipment & Packaging Characterization
- Experience defining operational parameters and ranges for assembly machines, cartoners, carton labelers, case packers, palletizers, accumulators, and labeling systems, while optimizing equipment performance.
Combination Product Regulations
- Working knowledge of FDA 21 CFR Part 4 requirements, including CGMP regulations under 21 CFR 211 and 21 CFR 820 / ISO 13485.
- Analytical & Material Science
- Experience with physical characterization techniques and evaluating the effects of mechanical testing, temperature variation, applied forces, and light exposure on materials.
- Statistical Analysis & DOE
- Experience applying Design of Experiments (DOE), Minitab, data analysis, and edge-of-failure testing methodologies.
- Technical Writing
- Ability to develop clear technical reports, protocols, executive summaries, and documentation based on engineering data.
Soft Skills & Competencies
- Strong systems-thinking abilities and understanding of packaging line interactions.
- Root cause analysis and problem-solving skills.
- Ability to work effectively across Engineering, Quality, Packaging Engineering, and Manufacturing teams.
- Strong organizational skills in fast-paced environments.
- Excellent verbal and written communication skills.
- Professional fluency in English (written and spoken).
- Flexibility to support first, second, or third shift operations as required.
#LI-ONSITE
#LI-LN1
