Validation Engineer (Plainsboro)

Summary :

We are seeking an experienced Validation Engineer with strong expertise in equipment and software qualification within medical device or pharmaceutical environments. This role supports the introduction and validation of new equipment, processes, and products, ensuring full regulatory compliance and high-quality outcomes. The ideal candidate is detail-oriented, technically skilled, and thrives in both independent and collaborative settings.

Key Responsibilities :

• Develop and execute qualification and validation protocols , including software qualification (risk assessments, data integrity, trace matrices).
• Conduct equipment and process qualification , including temperature mapping (experience with Kaye Validator probes preferred).
• Perform test method validation , gauge R&R , and DOE / statistical studies to support testing and manufacturing.
• Ensure compliance with cGMP, cGLP, QSR, and ISO standards.
• Prepare and manage validation documentation (protocols, deviations, summary reports).
• Support change control , risk management , and master validation planning activities.
• Collaborate cross-functionally to introduce and qualify new equipment, products, and processes.
• Maintain strong documentation and technical writing practices.
• Understanding of cleanroom gowning and cGMP environments is a plus.

Qualifications :