Validation Engineer

Ameri-partners; North Carolina; On-site; USD 95,000 - 135,000; Full time

Job summary

Ameri-Partners is seeking an experienced Equipment Validation Engineer to support packaging, manufacturing, and laboratory equipment validation within a regulated pharmaceutical environment.

The role emphasizes hands-on IQ/OQ/PQ development and execution, with strong troubleshooting, documentation, and cross-functional coordination across Engineering, Quality, and Vendors to maintain timeline and quality.

Qualifications

• 5+ years of equipment validation experience in regulated environments.
• Hands-on validation execution and testing.
• Ability to manage multiple projects with minimal supervision.

Responsibilities

• Develop, review, and execute IQ/OQ/PQ protocols for new and existing equipment.
• Support qualification of packaging, manufacturing, and laboratory equipment.
• Validate equipment such as blenders, grinders, ovens, furnaces, scales, balances, pH meters, and related production systems.
• Determine appropriate OQ operating ranges, test conditions, and parameters.
• Troubleshoot validation and equipment issues and drive resolution.
• Coordinate with Engineering, Manufacturing, Quality, Maintenance, Calibration, and vendors.
• Manage multiple validation activities while maintaining timelines and quality.

Skills

Equipment validation

IQ/OQ/PQ execution

GMP/GxP knowledge

Troubleshooting

Documentation

Project management

Job description

Ameri-Partners is seeking an experienced Equipment Validation Engineer to support packaging, manufacturing, and laboratory equipment validation activities within a regulated pharmaceutical environment.

About the Role

This is a hands-on validation role with a strong focus on packaging equipment, which will make up approximately 65% of the workload. The engineer will be responsible for independently developing, executing, and supporting equipment qualification activities while managing multiple projects with limited supervision.

Responsibilities

• Develop, review, and execute IQ/OQ/PQ protocols for new and existing equipment.
• Support qualification of packaging, manufacturing, and laboratory equipment.
• Validate equipment such as blenders, grinders, ovens, furnaces, scales, balances, pH meters, and related production systems.
• Determine appropriate OQ operating ranges, challenge conditions, and test parameters.
• Troubleshoot validation and equipment issues and drive them to resolution.
• Support equipment transfers, upgrades, replacements, and New Product Introduction (NPI) activities.
• Review equipment specifications, calibration records, procedures, and technical documentation.
• Support validation deviations, discrepancies, and final reports.
• Coordinate with Engineering, Manufacturing, Quality, Maintenance, Calibration, and equipment vendors.
• Manage multiple validation activities while maintaining project timelines and documentation quality.

Qualifications

• 5+ years of Equipment Validation experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.
• Strong hands‑on experience with IQ, OQ, and PQ execution.
• Experience determining and challenging equipment operating ranges during OQ.
• Ability to independently troubleshoot equipment and validation issues.
• Strong mechanical aptitude and hands‑on engineering skills.
• Strong technical writing and documentation capabilities.
• Working knowledge of GMP/GxP requirements.
• Ability to manage multiple projects with minimal supervision.

Preferred Skills

• Experience validating packaging equipment and packaging lines.
• Experience with manufacturing and laboratory equipment qualification.
• Knowledge of calibration and preventive maintenance activities.
• Experience supporting equipment transfers and NPI projects.
• Experience working with equipment OEMs and vendors.

This position is best suited for an engineer who can independently evaluate equipment functionality, determine appropriate qualification testing, execute protocols, and resolve issues in the field.