Validation Engineer
Job in
Washington, District of Columbia, 20022, USA
Listed on 2026-09-25
Listing for:
Medix™
Full Time
position Listed on 2026-09-25
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
- 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.
- 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 with in 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.
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