Validation Engineer - GMP/CSV for Medical Devices

the-pivot-group-careers; St. Johns (MI); On-site; USD 73,000 - 112,000; Full time

Job summary

The Pivot Group Network is seeking a Validation Engineer for opportunities in St. Johns, Michigan. The role focuses on developing and executing validation protocols, ensuring compliance with FDA/GMP, and collaborating with R&D, manufacturing, and quality teams.

Qualified candidates hold a Bachelor's in engineering, have 3+ years in regulated validation, and are proficient in IQ/OQ/PQ, data analysis, and programming (Python/SQL). The salary range is $73,000 to $112,000 depending on experience.

Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of validation experience in a regulated manufacturing environment.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with IQ, OQ, PQ protocols and reports.
• Proficiency in statistical analysis and data interpretation for validation purposes.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze validation data, write reports, and present findings.
• Investigate deviations and non-conformances during validation activities.
• Ensure regulatory compliance with FDA, GMP, and internal quality standards.
• Collaborate with cross-functional teams including R&D, manufacturing, and quality assurance.
• Maintain validation documentation throughout the equipment and process lifecycle.

Skills

Statistical analysis

Data interpretation

Regulatory knowledge

Education

Bachelor's degree in engineering or related discipline

Tools

Python

SQL

Job description

The Pivot Group Network is seeking a Validation Engineer for opportunities in St. Johns, Michigan. The role focuses on developing and executing validation protocols, ensuring compliance with FDA/GMP, and collaborating with R&D, manufacturing, and quality teams.

Qualified candidates hold a Bachelor's in engineering, have 3+ years in regulated validation, and are proficient in IQ/OQ/PQ, data analysis, and programming (Python/SQL). The salary range is $73,000 to $112,000 depending on experience.