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Pay Range: $24hr - $25hr

Responsibilities: Collects current equipment documentation to fill gaps or identify missing information. Working with Validation Engineers and quality assurance document control to implement necessary improvements. These may include modifications to existing documents, or collection and filing of current documents. Supports validation protocols for data collection, or creating documents, as assigned. Maintains compliance with regulatory agency guidance and client procedures. Assists with execution of equipment validation studies to include protocol execution, data analysis up to including control system administration such as software backups and system updates. Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.). Drafts commissioning and qualification protocols to sufficiently demonstrate the process is designed and fit for the intended use. Supports on-going system requalification and continuous improvement activities governed by change management processes. Skills: Possess an understanding of documentation organization, and ideally in a GMP environment. Must have excellent verbal and written communication skills, attention todetail, and problem solving skills. Must be experienced with Microsoft Office tools, i.e. Word, Excel, etc. Desirable to also have some basic mechanical skills. Preferred understanding of statistical analysis tools and/ or analytical methods. Education/Experience: BS/BA Degree in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility. 0 - 2 years pharmaceutical manufacturing experience.