Validation Engineer - Bothell
1 day ago
Job description
Summary
The main function of a Validation Engineer is to ensure that systems, equipment, and processes meet regulatory and performance standards through rigorous testing and documentation.
Manager Provided Responsibilities For The Role.
Provide lifecycle management for Quality Control lab instruments and related software systems.
Revise and/or obsolete validation documents and Standard Operating Procedures (SOPs).
Provide validation services for laboratory analytical instruments and controlled temperature units (CTU) to include writing, editing, executing protocols, and reviewing vendor validation documents in accordance with site requirements for validation activities.
Perform change control management activities:
authoring, performing, and tracking of change actions
Creating and performing investigations for Deviations/CAPAs
Perform instrument periodic reviews
Roles & Responsibilities
Design and execute validation protocols (IQ/OQ/PQ) for equipment, utilities, and processes Analyze test data and determine whether systems meet predefined acceptance criteria Document validation activities and maintain records in accordance with regulatory guidelines Collaborate with cross-functional teams to support product development and process improvements Investigate deviations and implement corrective and preventive actions (CAPAs) Ensure compliance with industry standards such as FDA, ISO, and cGMP Participate in audits and inspections, providing validation documentation and responses Stay current with validation trends, technologies, and regulatory update
Education & Experience
Strong analytical and problem-solving abilities Knowledge of validation principles, quality systems, and regulatory requirements Proficiency in statistical analysis tools and validation software Excellent written and verbal communication skills Ability to work independently and manage multiple projects Familiarity with laboratory and manufacturing environments
Bachelor's degree in Engineering, Life Sciences, or a related field required 5-7 years of experience in validation, quality assurance, or process engineering
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