The role serves as the principal point of contact for product knowledge, performance, and end-to-end process controls including critical quality attributes
Job Summary
The role serves as the principal point of contact for product knowledge, performance, and end-to-end process controls including critical quality attributes.
The engineer is accountable for implementing continued process verification, data trending, and statistical analysis to ensure processes remain in a validated state of control.
This position involves leading technical transfer activities for incoming products such as tablets, capsules, and powders while managing compliance records and investigations.
Matching Summary
The role serves as the principal point of contact for product knowledge, performance, and end-to-end process controls including critical quality attributes.
Skills & Requirements
Must-have
BS degree in Chemistry or Engineering
3+ years in Manufacturing Science
Knowledge of FDA and GMP regulations
Experience with SAP systems
Technical transfer of OSD formulations
Nice-to-have
Fluent in English and Spanish
Strong problem-solving skills
Ability to articulate business vision
Experience with continuous improvement tools
Teamwork and communication skills
Key Requirements
Bachelor's degree in Chemistry, Engineering, or related field
Minimum 3 years experience in Manufacturing Science or Technical Operations
Proficiency with FDA and GMP regulatory requirements