Sterling Engineering, Inc.
https://cdn.haleymarketing.com/templates/63335/logos/square_logo.png
https://www.sterling-engineering.com
https://www.sterling-engineering.com
USD
54.55
75.76
HOUR
true
Herman Davis
Validation Engineer - Clinical Equipment
2024-01-24
2024-03-24
Employment Type:
Contract
Job Category: Validation
Job Number: NG471308119
Compensation: $54.55-75.76 / hour
Job Description
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
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
Meet Your Recruiter
![](https://cdn.haleymarketing.com/images/team-members/102986/thumbs/teammember_thumb_small2x_square-E7EBC46A-8D3D-3D33-9CF5-253B1C8E393C.jpg)
Herman Davis
Technical Recruiter
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