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Onsite
Full-time
over 2024 years ago
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Summary
Azzur Group San Francisco is looking for a Process Engineer to join our growing San Francisco team. Working with a multi-disciplinary team, the process engineer ensures production line continues to operate and produce products for our client according to the established plan. In this hands-on role, the process engineer is the key liaison between in a fast-paced, collaborative, and multidisciplinary team, and will be responsible for the quality of work produced by their team. Experience with cGMP and FDA compliance is essential.
Essential Duties and Responsibilities:
* Represents TechOps department on project teams as technical subject matter expert (SME) and interface with site MSAT, Operations, and Quality functions.
* Develop process understanding and expertise.
* Authors, reviews and owns process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc)
* Authors, reviews change controls including managing change implementation of the change as the assigned change agent.
* Utilize technical skills and process knowledge to participate and/or lead investigations related to process/ New product implementation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
* Monitors and reports on process performance data analysis.
* Ability to share 24/7 on call support activities during production.
* Apply Operational Excellence principles to lead continuous improvement for downstream process improvements.
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