Validation Engineer

Overview

Develop and execute validation protocols, analyze data, and ensure product/process compliance.

Key Responsibilities

• validation testing
• test protocols
• doe/spc
• data analysis
• documentation
• capa management

Tasks

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

Requirements

• microsoft office
• cgmp
• python
• minitab
• science degree
• validation

What You Bring

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

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About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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