Job Description

Senior Validation Engineer

Location: Fremont, CA 94538 (Candidates must reside locally)

Employment Type: W2 Contract (6-month duration with potential for extension)

Start Date: April 2025

Work Arrangement: 100% On-site

Compensation: $64-$70/hr

Note: This is a W2 role

🧩 Position Summary

We are seeking a highly motivated Senior Validation Engineer to join our manufacturing team, with a strong focus on New Product Introduction (NPI) . This role is instrumental in ensuring equipment, systems, and processes are validated to meet regulatory and industry standards across all phases of medical device development and launch.

The ideal candidate brings a proven track record of managing validation protocols, technical documentation, and risk management — all while contributing to cross-functional NPI efforts. This position is suited for someone who thrives in a fast-paced environment, is detail-oriented, and possesses excellent problem-solving skills.

🔧 Key Responsibilities

• New Product Introduction (NPI) Support:
• Collaborate with Engineering, R&D, and Manufacturing to validate systems, processes, and equipment required to launch new medical devices.
• Validation of Equipment & Fixtures:
• Generate detailed equipment and fixture matrices for Minimum Viable Product (MVP) validation, ensuring compliance with medical device standards.
• Protocol Development & Execution:
• Develop and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols in line with regulatory requirements and internal standards.
• Performance Qualification (PQ):
• Conduct PQ validations to verify that manufacturing equipment operates consistently within required limits and specifications.
• Validation Reporting:
• Author validation completion reports that summarize findings, compliance status, and validation outcomes.
• SOP Development:
• Draft and implement Standard Operating Procedures (SOPs) for newly validated systems and processes to support consistent, compliant operations.
• Troubleshooting & Problem-Solving:
• Use root cause analysis and corrective/preventive action (CAPA) principles to resolve issues related to validation and manufacturing.
• Project Management:
• Lead and manage multiple validation projects , particularly related to NPI initiatives, ensuring deliverables are met on time and within scope.
• Documentation Control:
• Maintain and manage validation documentation in compliance with FDA, GMP, and ISO standards, ensuring traceability and audit readiness.

🎓 Education & Experience Requirements

• Bachelor’s degree in Engineering , Life Sciences , or a related technical field
• 3+ years of experience in a validation engineering role within the medical device , pharmaceutical , or regulated industry
• Demonstrated experience with NPI processes , including validation of new equipment, processes, and systems
• Solid understanding of GMP, ISO 13485 , FDA regulations, and relevant international standards (MDD/IVDR)
• Strong technical writing and verbal communication skills
• Proficiency in developing IQ/OQ/PQ documentation and reports

🌟 Desirable Skills & Certifications

• Knowledge of GD&T (Geometric Dimensioning & Tolerancing)
• Familiarity with Adaptiv or similar documentation management tools
• Six Sigma Green or Black Belt certification
• Cross-functional experience in design transfer , process development , and product launch support

✅ Why Join Us?

• Contribute to innovative medical device product launches
• Collaborate with a high-performing team across engineering, quality, and manufacturing
• Be part of an organization committed to quality, compliance, and continuous improvement
• Opportunity for contract extension based on project success and business needs

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