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Associate Validation Engineer

Grand Island, NY 14072

Posted: 01/24/2023 Employment Type: Contract Job Category: Engineering Job Number: 535754 Is job remote?: No Country: United States

Job Description

(target PR: 22/hr)
Summary:
Position may perform the following: documentation, analytical assessment, or data gathering.

The primary responsibility of this position is for support of qualification documentation filing, preparation or any responsibility surrounding data collection. Other department tasks may involve thermocouple assembly / calibration, data collection, system updates and other tasks as assigned.
Preferred excellent written and verbal communication skills, and ability to maintain cGMP compliance in accordance with worldwide guidance sources.

Job 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 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 to detail, 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.
 
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