This role serves as the principal point of contact for product knowledge, performance, and end-to-end process controls including critical quality attributes
Job Summary
This 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 products remain in a validated state of control.
Responsibilities include leading technical transfers for oral solid dosage formulations such as tablets, capsules, and powders while managing compliance records and investigations.
Matching Summary
This 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
Minimum 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
Experience with Veeva and eBR systems
Strong project management skills
Ability to articulate business vision
Teamwork and communication skills
Key Requirements
BS degree in Chemistry, Engineering, or related area
Minimum 3 years experience in Manufacturing Science or Technical Operations