Validation Engineer - Fill-Finish & GMP Compliance

United Pharma Technologies Inc; North Carolina; On-site; USD 80,000 - 110,000; Full time

Job summary

United Pharma Technologies Inc seeks experienced Validation Engineers to support annual revalidation activities for fill-finish operations at a pharmaceutical facility in Greenville, NC. The role demands hands-on validation expertise in GMP-regulated settings and strong collaboration with Manufacturing, Engineering, and QA teams.

You will execute IQ/OQ/PQ, review documentation, ensure audit readiness, and maintain compliant validation records while supporting investigations and change controls

Qualifications

• Hands-on validation experience in pharma/biotech environments.
• Experience with fill-finish, filling and/or sterilization validation.
• Familiar with IQ/OQ/PQ and process validation principles.
• Knowledge of GMP requirements and FDA regulations.
• Strong documentation and cross-functional collaboration skills.

Responsibilities

• Support annual revalidation activities for fill-finish and filling processes.
• Execute and review validation protocols, including IQ, OQ, PQ, and revalidation.
• Support sterilization revalidation activities and related documentation.
• Review validation records for compliance with procedures.
• Prepare, review, and maintain validation protocols, reports, deviations, and supporting documentation.
• Collaborate with Manufacturing, Engineering, QA, and Validation teams.
• Support investigations, deviations, and change controls related to validation.
• Ensure activities are performed in accordance with GMP, FDA regulations, and site procedures.
• Maintain audit-ready validation documentation.

Skills

Pharma validation

Fill-finish validation

IQ/OQ/PQ

GMP/FDA knowledge

Documentation

Cross-functional collaboration

Job description

United Pharma Technologies Inc seeks experienced Validation Engineers to support annual revalidation activities for fill-finish operations at a pharmaceutical facility in Greenville, NC. The role demands hands-on validation expertise in GMP-regulated settings and strong collaboration with Manufacturing, Engineering, and QA teams.

You will execute IQ/OQ/PQ, review documentation, ensure audit readiness, and maintain compliant validation records while supporting investigations and change controls