Validation Engineer

Actalent•Camarillo, CA

34d•$100,000 - $105,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.