| Location | Clayton, NC |
Responsibilities: for the Validation Engineer Include: · Execute validation protocols (IQ/OQ/PQ) for aseptic fill-finish equipment. · Support validation documentation, deviations, and change controls. · Collaborate with cross-functional teams including QA, Engineering, and Manufacturing. · Ensure compliance with cGMP, FDA, and internal quality standards. Requirements for the Validation Engineer Include: · 7 years of validation experience in aseptic pharma manufacturing. · Experience with filling isolator equipment is highly preferred. · Experience with Optima filling lines is a strong plus. · Familiarity with TIMS (a validation lifecycle management system similar to Kneat) is desirable. · Strong understanding of regulatory requirements and validation best practices.