Validation Engineer - 254542

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

• Lead the planning, development, execution, and review of IQ, OQ, and PQ validation protocols for manufacturing equipment, utilities, and process systems.
• Develop and maintain Validation Master Plans (VMPs), ensuring compliance with FDA 21 CFR Part 820, ISO 13485, GMP requirements, and internal quality standards.
• Establish validation strategies, including acceptance criteria, sampling plans, and statistical rationale.
• Manage the site validation matrix to ensure validated systems remain compliant and revalidation requirements are identified and executed.
• Author and review validation deliverables, including protocols, summary reports, deviations, and change control documentation.
• Support Computer System Validation (CSV) activities for manufacturing software and data acquisition systems as required.
• Lead investigations and root cause analyses related to validation failures, manufacturing yield losses, and customer complaints using methodologies such as 5-Why, Fishbone, and FMEA.
• Partner with Production and Quality teams to develop, implement, and maintain SOPs and training programs for validated processes.
• Support continuous improvement initiatives focused on safety, process capability, equipment performance, lead-time reduction, and waste elimination while ensuring compliance with validation and change control requirements.
• Participate in equipment qualification, commissioning, and validation activities for new equipment installations and technology transfers.
• Support equipment transportation, installation, startup, troubleshooting, and testing activities
• Maintain audit-ready validation documentation within the Quality Management System (QMS).
• Serve as a validation subject matter expert during internal audits, customer audits, and regulatory inspections.
• Collaborate with Regulatory Affairs and Quality Assurance to assess validation impacts associated with design changes, supplier changes, process improvements, and quality system updates.

Qualification:

• Bachelor's degree in Engineering or a related technical discipline.
• 2+ years of experience in Validation Engineering, Process Engineering, or a related manufacturing role.
• Experience within medical device, pharmaceutical, or other highly regulated manufacturing environments.
• Demonstrated hands‑on experience authoring, executing, and reporting IQ, OQ, and PQ validation protocols.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP requirements, and quality system regulations.
• Excellent technical writing and documentation skills with the ability to create clear, defensible validation records.
• Working knowledge of statistical tools and methodologies, including sampling plans, process capability analysis (Cp/Cpk), and Gauge R&R studies.
• Proven ability to manage multiple projects simultaneously and deliver results against aggressive timelines.
• Experience with Change Control, CAPA, Nonconformance, and Deviation Management systems.