Validation Engineer II
hace 6 días
We are looking for a Validation Engineer II (Packaging) in the second shift to support and implement changes in packaging and manufacturing processes for medical device product lines. This role includes supporting validation of equipment and product processes, ensuring compliance with regulatory standards, and contributing to continuous improvement initiatives.
KEY RESPONSIBILITIES:
Support implementation of changes in packaging components that make up the sterile barrier system, including primary, secondary, and protective packaging.
Assist in improving and optimizing manufacturing processes related to medical device products.
Execution of packaging and process validation protocols (IQ, OQ, PQ, TMV) and preparation of associated reports.
Participate in validation of manufacturing equipment and medical device product processes.
Assist in change management and change control activities (validation, process, equipment updates).
Support engineering change orders (ECOs).
Conduct verification runs, collect data, and assist in generating technical documentation.
Support DOE activities, Gage R&R (TMV), PFMEA, and Process Capability Analysis (CPK/PPK).
Ensure compliance with ISO and FDA regulatory requirements for medical devices.
BASIC QUALIFICATIONS:
Bachelor's degree in Engineering or related field.
2+ years of experience in manufacturing or process engineering.
2+ years of experience in the Medical Device industry.
Experience supporting process development or process improvement projects.
Experience supporting equipment validation and/or medical device product process validation.
Experience assisting with IQ/OQ/PQ protocol execution and documentation.
Knowledge of ISO 13485, ISO 11607, and 21 CFR Part 820.
Packaging experience within regulated environments preferred.
Basic knowledge of packaging test methods and laboratory equipment.
Intermediate level of English (reading, writing, and conversational).
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