DSJ Global · 1 day ago

Process Engineer

Georgia, United States

Full-time

Onsite

Mid Level

3+ years exp

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Responsibilities

Develops, evaluates, and makes recommendations for manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.

Prepares protocols for processes or performance testing of new or modified manufacturing equipment, processes, or systems.

Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.

Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.

Reviews GMP documents (MBRs, SOPs, protocols) and generates change controls.

Assist in writing proof of principle protocols, assist in writing and developing design specifications and IQ/OQ/PQ protocols.

Identifies non-conformances of product or process standard and offers recommendations for resolving deviations.

Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notes.

Modifies testing methods or revisits test objectives and standards to resolve testing problems.

Ensures product and process quality by designing testing methods; testing finished-product and process capabilities; establishing standards; confirming manufacturing processes.

Qualification

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Manufacturing Process EngineeringPowder FillingCGMP Environment