Validation Engineer

BOXX Technologies; Austin (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

BOXX Technologies is seeking a Validation Engineer to lead the development, execution, and documentation of validation protocols ensuring production processes and equipment meet quality and regulatory standards. The role focuses on driving continuous improvement in product quality, compliance, and operational efficiency within a manufacturing environment.

You will work with cross-functional teams to plan, execute, and document validation activities including process validation, IQ/OQ/PQ,

Qualifications

• Strong knowledge of regulatory and legal standards in production (FDA regulations, ISO 13485, GMP, HACCP).
• Expertise in audits, quality control, and quality management systems.

Responsibilities

• Develop validation plans, protocols, and reports aligned with GMP, ISO 13485, and FDA requirements.
• Execute validation activities: process validation, IQ/OQ/PQ, cleaning validation, and software validation.
• Conduct risk assessments and gap analyses to drive process improvements and compliance.
• Perform regular quality audits to verify adherence to regulatory standards and internal policies.
• Collaborate with manufacturing, QA, engineering and regulatory teams to support product safety and compliance.
• Maintain meticulous documentation of validation procedures, deviations, changes, and status reports.
• Lead investigations into validation failures and deviations, implementing corrective actions.

Skills

Regulatory compliance

Quality audits

QA/QC processes

GAMP / Six Sigma

Lean manufacturing

Project management

Cross-functional collaboration

Validation execution

Job description

Job Overview

We are seeking a dynamic and detail-oriented Validation Engineer to join our innovative manufacturing team. In this pivotal role, you will lead the development, execution, and documentation of validation protocols to ensure our production processes and equipment meet stringent quality standards and regulatory requirements. Your expertise will drive continuous improvement in product quality, compliance, and operational efficiency. This position offers an exciting opportunity to contribute to high-quality manufacturing environments while working with cross-functional teams committed to excellence.

Job Overview

We are seeking a dynamic and detail-oriented Validation Engineer to join our innovative manufacturing team. In this pivotal role, you will lead the development, execution, and documentation of validation protocols to ensure our production processes and equipment meet stringent quality standards and regulatory requirements. Your expertise will drive continuous improvement in product quality, compliance, and operational efficiency. This position offers an exciting opportunity to contribute to high-quality manufacturing environments while working with cross-functional teams committed to excellence.

Duties

• Develop comprehensive validation plans, protocols, and reports aligned with industry standards such as GMP (Good Manufacturing Practice), ISO 13485, and FDA regulations.
• Execute validation activities including process validation, equipment qualification (IQ/OQ/PQ), cleaning validation, and software validation.
• Conduct risk assessments and gap analyses to identify areas for process improvement and compliance enhancement.
• Perform regular quality audits to verify adherence to HACCP, CGMP, ISO 9001, Lean management principles, and other regulatory standards.
• Collaborate with manufacturing, quality assurance, engineering, and regulatory teams to ensure validation activities support overall product safety and compliance goals.
• Maintain meticulous documentation of validation procedures, deviations, change controls, and validation status reports.
• Lead investigations into validation failures or deviations, implementing corrective actions promptly to uphold quality systems.

Skills

• Strong knowledge of regulatory/legal compliance standards in production such as FDA regulations, ISO 13485, GMP, and HACCP.
• Expertise in quality audits, quality control processes, and quality management systems.
• Proficiency in manufacturing processes with a focus on quality assurance (QA/QC) practices.
• Skilled in analysis techniques including GAMP (Good Automated Manufacturing Practice), GD&T (Geometric Dimensioning & Tolerancing), Six Sigma methodologies, and lean management tools.
• Excellent project management capabilities with the ability to lead cross-functional teams effectively.
• Demonstrated experience practicing in an industrial or manufacturing engineering role with a focus on validation activities.
• Strong communication skills for clear reporting and collaboration across departments.
• Ability to interpret technical specifications and conduct thorough analysis for continuous process improvement.

Join us as a Validation Engineer if you’re passionate about ensuring the highest standards of quality in manufacturing environments! Bring your expertise in validation protocols, regulatory compliance, and process optimization to help us deliver safe, reliable products while advancing your career in a fast-paced industry dedicated to excellence.