Validation Engineer - Clinical Equipment

Lead the validation efforts for laboratory instruments in a highly automated, high throughput clinical assay setting. Work closely with Clinical Lab Managers, Quality System Administrators, and Equipment and Process Engineers to qualify new instruments at the site.



Responsibilities:



Translate Requirements: Convert User Needs, System Requirements, and assay tolerances into technical specifications.



Collaborate: Partner with various stakeholders to qualify new instruments and update the Equipment Qualification Master Plan.



Documentation: Author various validation documents such as risk assessments, user requirements, validation plans, and protocols. Ensure adherence to regulatory guidelines.



Compliance: Ensure lab instruments comply with regulatory guidelines (cGMP, FDA 21 CFR Part 11, CLIA, and CAP). Formulate strategies for systems with compliance gaps.



Periodic Reviews: Conduct periodic reviews of laboratory instruments and control software, focusing on change control, deviation investigations, and CAPA.



Integration: Identify and integrate qualification procedures into existing workstreams in consultation with Operations Team stakeholders.



Data Analysis: Analyze data from multiple sources to balance operator efficiency, cost of goods, and system uptime while maintaining compliance.



Documentation and Training: Write and maintain user manuals, SOPs, and work instructions. Train junior engineers on protocol execution.



Quality Review: Review validation deliverables created by others for adherence to site validation SOPs and act as a validation approver when needed.



Requirements:



Education: BS in Engineering or Life Sciences Discipline.

Experience: Minimum of five years delivering qualified equipment in a manufacturing or production environment.

Knowledge: Proficient in FDA Regulations/Guidance, ISO 13485, and Medical Device validation/qualification requirements.

Skills: Strong statistical analysis skills, ability to manage multiple activities, familiarity with lab operations, and excellent communication skills.

Preferred Skills: Master’s Degree, experience with automated liquid handlers or custom robotics, familiarity with molecular biology laboratory equipment, and experience in a clinically regulated environment.

Demonstrated understanding of global regulations on data integrity (FDA 21 CFR Part