Validation Engineer

Creative Solutions Services, LLC; San Jose (CA); On-site; USD 120,000 - 190,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced Validation Engineer to lead IQ/OQ/PQ validation for medical device manufacturing processes in California. You will collaborate with Engineering and Quality to ensure products meet stringent quality standards.

Requires 8+ years in regulated validation, strong injection molding and cleaning validation experience, and knowledge of FDA 21 CFR Part 820, ISO 13485, GMP.

Qualifications

• 8+ years of validation experience in medical devices or regulated industries.
• Strong expertise in injection molding and plastic materials.
• Hands-on experience with cleaning validation and contamination control.
• Solid understanding of the validation lifecycle (IQ/OQ/PQ) and statistical analysis.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and GMP.

Responsibilities

• Develop and execute validation plans and reports.
• Analyze data and troubleshoot process deviations.
• Ensure compliance with FDA regulations and ISO standards.
• Collaborate with Engineering and Quality teams to drive continuous improvement.

Skills

Validation engineering

IQ/OQ/PQ lifecycle

Regulatory compliance

Data analysis

Cross-functional collaboration

Job description

Summary:

In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. You will work cross‑functionally to ensure the products meet the highest quality standards.

Roles & Responsibilities:

• Develop and execute validation plans and reports.
• Analyze data and troubleshoot process deviations.
• Ensure compliance with FDA regulations and ISO standards.
• Collaborate with Engineering and Quality teams to drive continuous improvement.

Required Qualifications:

• 8+ years of validation experience in the medical device or other regulated industry.
• Strong expertise in injection molding and plastic materials.
• Hands‑on experience with cleaning validation and contamination control.
• Solid understanding of the validation lifecycle (IQ/OQ/PQ) and statistical analysis.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).