Job Description: The Quality Engineer provides a critical link between the Innovation team including Implementation and Support (I&S) Engineering (PD&I) Category Technical Managers Plant Operations and Quality.
Responsibilities: - Provide daily support to the plant to address quality issues and continuous improvement initiatives by spending time in the production area and participating in the site Standard.
- Interface effectively with key business partners including Operations Technology Business Unit Procurement and Vendors to drive Company results.
- Process Validation & Control.
- Oversees the validation program including C&S conducts risk analysis maintains and updates validation master plan develops validation protocols for PQ supports IQ/OQ in conjunction with the engineering team.
Requirements: - Bachelors degree in chemical / mechanical engineering Chemistry or related science/engineering discipline.
- 2 years of experience in manufacturing a quality role or equivalent.
- A strong background in quality systems validation understanding of cGMP and 21 CFR 210 & 211 and experience in working in a regulated industry (i.e. FDA).
- Working knowledge of SAP validation software (KNEAT) IN Batch systems.