Validation Specialist Engineer

Generating, executing, and reviewing protocols for controlled temperature units and packaging equipment. .
Analyze validation test data to determine whether systems or processes have met validation acceptance criteria or to identify root causes of production problems.
Identify deviations from established product or process standards and provide recommendations for resolving deviations.
Prepare, maintain, or review validation and compliance documentation, such as engineering change controls, schematics, or protocols.
Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production
Summarize Protocol execution and results for the IQ/OQ/PQ Summary Report
Perform Document/SOP Writing
Coordinate Validation Projects and ensure project timelines
Manage and maintain all validation test equipment.
Manage and maintain all Refrigerators, Freezers (CTUs) and Walk-In Cold Rooms/ Warehouse Storage Facilities within a proper validated state according to FCS standards.
Basic Minimum Qualifications (BMQ):
Must provide direction to team and external department related functions and activities
Must have strong interpersonal skills
Must have strong analytical skills
Must be able to multitask and respond to shifting priorities
Must be proficient with computer software (MS Office) and have expertise with spreadsheets
Must have good communication skills, both written and verbal
Must have prior mechanical and process equipment experience
Must be results oriented

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