Validation Engineer - Nebraska City, United States - Germer International
Description
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.
Responsibilities:
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 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.
Requirements:
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.
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.
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