Nebraska City, NE
As a Validation Engineer, you will be responsible for supporting the function and responsibilities of our client’s Technical Services/Product Research and Development department in collaboration with other organizational departments.
- You will support the troubleshooting of operations and processing issues by performing lab-scale processing and/or data analysis review.
- You will support developing new and optimizing current product for both internal and external production.
- You will lead the development, implementation and closure of Change Controls, Deviation investigations and Corrective Actions/Preventative Actions (CAPA) within a timely manner.
- You will generate and execute Installation/Operational/Process Qualification/Process Validation (IQ, OQ, PQ, PV) protocols and related summary reports.
- You will support the Validation Master Plan and Calibration program activities in accordance with current USDA and FDA cGMPs.
- You will collaborate with others to identify areas of improvements and facilitate the revision and approval of Standard Operation Procedures (SOP), Manufacturing Instructions (MI) and other documents.
- You will perform risk assessments and support implementation of identified improvements.
- You will have a bachelor’s degree in a Science related field with a minimum of 6 years’ experience in an USDA and/or FDA regulated industry, preferred.
- (Preferred) You will have a Masters and/or PhD degree in sciences.
- You will have a minimum of 3 years of qualification/validation experience.
- You will have knowledge of US FDA 21 CFR Part 117 and Q7 cGMP requirements.
- You will be self-motivated with a results driven approach and have the ability to manage multiple projects/tasks simultaneously.
- You will have strong written and verbal communication skills, including the ability to organize information and present it to peers and members of Senior Management.
- You will be proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.