Validation Engineer

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

We are seeking experienced Validation Engineers to support annual revalidation activities for fill-finish manufacturing operations at a pharmaceutical facility in Greenville, NC. The ideal candidate will have hands-on experience with pharmaceutical/biotech validation, particularly in filling, fill-finish, sterilization, and GMP-regulated manufacturing environments.

Key Responsibilities

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

Required Qualifications

• Hands-on experience in pharmaceutical or biotech validation.
• Strong experience with fill-finish, filling, and/or sterilization validation.
• Experience supporting annual revalidation programs in a GMP-regulated environment.
• Working knowledge of IQ/OQ/PQ and process validation principles.
• Experience with validation documentation, deviations, investigations, and change controls.
• Strong understanding of GMP requirements and FDA regulations.
• Excellent documentation, communication, and cross-functional collaboration skills.

Preferred:

• Experience within aseptic or sterile pharmaceutical manufacturing environments.
• Experience supporting validation activities for manufacturing equipment and processes.
• Familiarity with validation lifecycle and audit-readiness requirements.