Validation Engineer
Listed on 2026-01-02
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Engineering
Quality Engineering, Biomedical Engineer
Job Title:
Validation Engineer
We are seeking a dedicated and skilled Validation Engineer to join our team. The successful candidate will be responsible for developing and executing validation protocols, analyzing test data, and ensuring product and process standards are met. This role requires collaboration with various departments to implement validation testing and resolve any testing anomalies.
Responsibilities- Consult with management to evaluate customer requirements and study 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 standards 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 and 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 Corrective And Preventive Action (CAPA) implementation, and generating or supporting ECR & ECO 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.
- 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.
Skills & Qualifications
- Coding experience a plus, python preferred.
- Experience with Minitab or other statistical software a plus.
- Experience with benchtop electrical wiring a plus.
- Degree in science, engineering, biology, or related technical field.
This position requires working closely with cross-functional teams in a dynamic laboratory setting. The role involves using advanced statistical tools and software, and requires a thorough understanding of validation processes in a regulated industry. The work environment is collaborative, with opportunities to engage with scientists and engineers to develop and refine product specifications.
Pay and BenefitsThe pay range for this position is $100000.00 – $105000.00/yr. see benefits page at
Final date to receive applicationsThis position is anticipated to close on Nov 30, 2025.
About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.
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