Houston Metro Area, TX
Develop and execute software, packaging, and labeling equipment validation protocols.
Develop user, functional, and regulatory requirements.
Develop test plans and summary reports.
Minimum of 5-7 years experience in medical device or pharma industries, with at least 2 years in labeling systems
Must be familiar with SDLC, CSV life cycle, and documenting commissioning activities (F.A.T. and S.A.T. testing, process, software and equipment acceptance criteria).
Must be able to independently create a User Requirements Specification by interviewing subject matter experts.
Must be able to independently create a Traceability Matrix from the URS and validation protocols.
Must be able to independently create a validation protocol from the User Requirements Specification.
Must be familiar with UDI requirements, medical device /drug labeling requirements, and 21CFR Part 11 requirements.
Must have experience validating manufacturing equipment, including computer controlled systems (PLC, HMI, Allen Bradley) and vision and inspection systems (Cognex). Packaging and labeling equipment validation experience a plus.
Must be able to learn software, packaging, and labeling equipment in order to create test cases and expected results.
Must be familiar with typical packaging and labeling equipment (label applicators, vision systems, and label template software).
Must be proficient in MS Office applications. Knowledge of Bartender, .NET, AS400, and SQL a plus.
|BS in a technical or scientific field.|