Validation Engineer

Detail-oriented Validation Engineer with hands-on experience supporting packaging equipment validation and regulatory documentation activities within GMP-regulated manufacturing environments. Provides technical and documentation support for IQ/OQ/PQ execution, protocol development, discrepancy resolution, and change management related to primary, secondary, and tertiary packaging systems.

Qualifications:

• Experienced in assisting with preparation, review, and maintenance of validation lifecycle documentation including Validation Master Plans (VMPs), User Requirements Specifications (URS), risk assessments (FMEA), traceability matrices, and final reports. Collaborates cross-functionally with Quality, Regulatory Affairs, Engineering, and Manufacturing to ensure packaging systems remain compliant with FDA and global regulatory standards.
• Demonstrates strong organizational skills and attention to detail in supporting audit readiness, document control processes, data integrity compliance, and continuous improvement initiatives. Adept at coordinating validation activities, tracking deliverables, and ensuring timely closure of documentation to maintain validated state of packaging operations.

1st Shift - 8:00 AM to 5:00 PM

• Bachelors degree in Engineering with 3 to 5 years of relevant experience.

Job Types: Full-time, Contract

Work Location: In person