Validation Engineer

Midland-Marvel Recruiters, LLC; Camarillo (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

A growing manufacturing company in California is looking for a Validation Engineer to conduct product, process, and equipment validations. The role involves collaboration with cross-functional teams and requires a Bachelor's degree in a related field and 2-5 years of experience in validation or quality testing. Ideal candidates should have excellent communication skills and a good understanding of regulatory guidelines. Competitive salary and benefits are offered.

Qualifications

• 2-5 years of experience in validation, quality, or laboratory testing in a regulated industry.
• Thorough understanding of applicable mathematics, statistical, and scientific practices.

Responsibilities

• Consult with management to select validation objectives and standards.
• Prepare clear, compliant test protocols for validation of products.
• Analyze data from validation tests using statistical tools.
• Collaborate with departments regarding scheduling of validation testing.

Skills

Excellent verbal and written communication skills

Excellent interpersonal skills

Thorough understanding of industry standards and regulatory guidelines

Proficient with Microsoft Office Suite

Education

Bachelor’s degree in science, engineering, biology, or related technical field

Tools

Minitab

Job description

Overview

About the Company. Growing company with multiple manufacturing locations has an exciting opportunity available for a Validation Engineer.

The Validation Engineer will collaborate with stakeholders at all company locations to conduct product, process and equipment validations, risk assessments, develop testing methods and various test/process validation requirements. This individual will support cross functional teams to ensure product or process verification supports all internal and product compliance requirements.

About the Role

The Validation Engineer will collaborate with stakeholders at all company locations to conduct product, process and equipment validations, risk assessments, develop testing methods and various test/process validation requirements.

Responsibilities

• Consult with management, evaluate customer requirements, and studies product characteristics to select validation objectives and standards.
• Prepare clear, compliant test protocols for validation or performance testing of new or existing products, equipment, processes, or systems.
• Analyze data from validation tests using statistical tools (DOE, capability analysis) to determine whether results meet required criteria and specifications.
• Maintain technical records within design history files associated with assigned products.
• Collaborate and coordinate with appropriate departments and staff regarding the scheduling or implementation of validation testing.
• Assist in investigations of test anomalies and validation failures.
• Identify nonconformities of product or process standard and offer recommendations for resolving deviations.
• Use databases for tracking test results, validation activities, or validated systems.
• Develop, maintain, or review validation and compliance documentation including schematics, protocols, and engineering change notices.
• Modify testing methods, revisit test objectives and standards to resolve testing problems.
• Develop test methods, generate, and maintain design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
• Support Product Delivery Teams (PDT), including creating and or reviewing quality documents, participating in CAPA implementation, and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order) activities.
• Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
• Maintain accurate sample inventory, status, and study tracking within lab systems.
• Perform other related duties as assigned.

Qualifications

• Bachelor’s degree in science, engineering, biology, or related technical field.

Required Skills

• 2-5 years of experience in validation, quality, or laboratory testing in a regulated industry.
• Excellent verbal and written communication skills.
• Excellent interpersonal skills.
• Thorough understanding of industry standards and regulatory guidelines (cGMP, FDA, etc.) preferred.
• Thorough understanding of applicable mathematics, statistical, and scientific practices.
• Thorough understanding of related equipment and the ability to perform equipment modifications.
• Proficient with Microsoft Office Suite or related software.
• Experience with Minitab or other statistical software a plus.
• Experience with benchtop electrical wiring a plus.

Preferred Skills

• Experience with Minitab or other statistical software a plus.
• Experience with benchtop electrical wiring a plus.

Equal Opportunity Employer

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