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DSJ Global is partnered with an industry leading pharmaceutical company who is looking to add a Process Engineer to their team. The Process Engineer will conduct activities to develop and improve manufacturing processes by studying product and manufacturing methods, preparing analyses reports, presenting information and making recommendations to solve problems and/or improve processes while following cGMP rules and regulations.
The Process Engineer will be responsible for:
* 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.
The Process Engineer should have:
* Bachelor's degree in related field required.
* 3 years of experience as a manufacturing process engineer
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