Validation Engineer

Our client is a biotechnology/medical device company looking to add a Validation Engineer to their team in Ventura County, CA.

Salary/Hourly Rate

$100k - $110k

The Validation Engineer will lead validation activities for products, processes, and equipment across multiple sites. This role includes developing test methods, conducting risk assessments, and ensuring compliance with internal standards and regulatory requirements. The Validation Engineer role requires collaboration with cross-functional teams to support product verification and process optimization.

• Define validation objectives and standards based on product and customer requirements.
• Develop and execute compliant validation protocols for products, equipment, and processes.
• Analyze validation data using statistical tools (DOE, capability analysis) to confirm compliance.
• Maintain technical documentation within design history files.
• Coordinate scheduling and implementation of validation activities.
• Investigate anomalies and failures during validation testing and recommend corrective actions.
• Track validation activities and results using appropriate systems.
• Prepare and review validation documentation, including schematics, protocols, and engineering change notices.
• Modify test methods and standards to resolve issues and optimize processes.
• Support product development teams with quality documentation, CAPA activities, and engineering change requests/orders.
• Collaborate with internal and external scientists and engineers to establish design and manufacturing specifications.
• Maintain accurate sample inventory and study tracking within laboratory systems.
• Perform additional duties as assigned.

• 2 - 5 years of experience in validation, quality assurance, or laboratory testing within a regulated industry.
• Strong verbal and written communication skills.
• Familiarity with industry standards and regulatory guidelines (cGMP, FDA).
• Proficiency in statistical and scientific practices. Experience with DOE/SPC is preferred.
• Skilled in Microsoft Office Suite; experience with Minitab or similar statistical software is a plus.
• Coding experience (Python preferred) and benchtop electrical wiring knowledge are advantageous.

Bachelor's degree in Science, Engineering, Biology, or a related technical field is required.

• Medical, dental, and vision plans.
• Flexible Spending Accounts (FSA).
• Life and AD&D insurance.
• Disability coverage.
• Employee Assistance Program (EAP).
• 401(K) retirement plan.
• Additional wellness and referral programs.

As a woman‑owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Candidates who apply for roles through Atrium’s website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.

EOE/M/F/D/V/SO