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Validation Engineer

Bothell, WA, US • Posted 30+ days ago • Updated 3 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Testing
Research
Lifecycle Management
Quality Control
Standard Operating Procedure
Writing
Editing
Change Control
IQ
OQ
PQ
Collaboration
Product Development
Process Improvement
Regulatory Compliance
ISO 9000
Good Manufacturing Practice
Auditing
Documentation
Analytical Skill
Problem Solving
Conflict Resolution
Quality Management
Statistics
Communication
Management
Manufacturing
Life Sciences
Quality Assurance
Process Engineering

Summary

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. A typical Validation Engineer develops protocols, executes validation activities, and supports compliance across manufacturing or research environments.
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.
4. 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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 783cf0c2d8dc64a918b446afdfa3c2a3
Posted 30+ days ago

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