Irvine, CA, us
Company: Vastek Inc
Published on 2021-10-21 19:23:10
Job Description Hello, We are urgently seeking a Process Engineer . Responsibilities:- Support commercial drug product manufacturing operations with technical evaluation of CAPA, scale up, validation, and technology transfer. This includes drug product manufacturing (material preparation, mixing, molding, and inspection) and reserve samples (creation, storage, and testing). Support of regulatory filings and inspections. Troubleshoot issues with drug product processing technologies and equipment. Projects involve collaborating with cross-functional teams developing and executing tests, performing root cause analysis and participating in investigations. Also making presentations to internal/external customers, vendors, and senior management Conduct risk assessment for drug product operations non conformances, change controls, and implement appropriate CAPAs. Lead process modelling, data trending and advanced statistical & process analysis – present data/metrics to teams. Qualifications and Education:- BS/MS in Chemical/Biochemical Engineering, Polymer Sciences/Engineering, Mechanical Engineering,Industrial Engineering, Biomedical Engineering, or Science Bachelor's Degree 1 -5 years of Process Engineering or Operations experience . Strong knowledge of Quality systems, drug product manufacturing and process validation. Work history with cGMPs, regulatory filings and compliance issues. Thanks Suchi suchivastekgroup.com Company Description Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in IT and consulting. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Healthcare, Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies. We supply consultants to top 500 Inc Companies. We are E-verified company.