Senior Validation Engineer - IQ/OQ/PQ for Med Devices

Medix™; Washington, Baltimore (District of Columbia, MD); On-site; USD 105,000 - 150,000; Full time

Job summary

Medix in Washington, DC seeks a Validation Engineer to lead IQ/OQ/PQ validation for manufacturing equipment and processes. The role ensures compliance with FDA 21 CFR Part 820, ISO 13485, GMP and maintains audit-ready records.

Responsibilities include VMP maintenance, strategy development, sampling plans, and statistical rationale. Collaboration with Quality/Regulatory, CSV support, and CAPA/Change Control activities are essential.

Qualifications

• Bachelor's degree in Engineering or related discipline.
• 2+ years in Validation Engineering, Process Engineering, or related manufacturing.
• Experience in medical device or other highly regulated manufacturing environments.
• Hands-on authoring, executing, and reporting IQ, OQ, and PQ validation protocols.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP and quality systems.
• Excellent technical writing and documentation skills.
• Knowledge of sampling, Cp/Cpk, Gauge R&R and statistics.
• Ability to manage multiple projects against aggressive timelines.
• Experience with Change Control, CAPA, Nonconformance, and Deviation Management.

Responsibilities

• Lead planning, development, execution, and review of IQ, OQ, and PQ validation protocols for equipment, utilities, and processes.
• Develop and maintain Validation Master Plans (VMPs) compliant with FDA/ISO GMP standards.
• Establish validation strategies, acceptance criteria, sampling plans, and statistical rationale.
• Manage site validation matrix to ensure ongoing compliance and revalidation.
• Author and review validation deliverables and associated change control docs.
• Support CSV activities for manufacturing software and data acquisition systems.
• Lead investigations using 5-Why, Fishbone, and FMEA for validation issues.
• Collaborate with Production/Quality to develop SOPs and training for validated processes.
• Maintain audit-ready validation docs within the QMS and support regulatory inspections.
• Participate in equipment qualification, commissioning, and technology transfers.

Skills

Validation engineering

GMP knowledge

Technical writing

Project management

Statistical analysis

Root cause analysis

Regulatory compliance

Education

Bachelor's degree in Engineering

Job description

Medix in Washington, DC seeks a Validation Engineer to lead IQ/OQ/PQ validation for manufacturing equipment and processes. The role ensures compliance with FDA 21 CFR Part 820, ISO 13485, GMP and maintains audit-ready records.

Responsibilities include VMP maintenance, strategy development, sampling plans, and statistical rationale. Collaboration with Quality/Regulatory, CSV support, and CAPA/Change Control activities are essential.