Senior Validation Specialist – Packaging & GMP

Pinnaql, Inc.; Allentown (Lehigh County); On-site; USD 75,000 - 95,000; Full time

Job summary

Validation & Engineering Group, Inc. in Allentown is seeking a Validation Specialist to support qualification of packaging equipment. The role focuses on developing, executing, reviewing, and closing IQ/OQ/PQ protocols with strong GMP and data integrity practices.

The ideal candidate has 5+ years of cGMP equipment validation experience, excellent technical writing skills, and the ability to coordinate with Quality, Engineering, and Operations to protect schedules and quality.

Qualifications

• Bachelor’s degree in engineering or science.
• At least 5 years of equipment validation in a cGMP pharmaceutical environment.
• Experience independently developing IQ/OQ/PQ protocols.
• Knowledge of validation lifecycle documentation, change control, deviation management, CAPA, risk assessment, and traceability.

Responsibilities

• Develop, review, execute, and close IQ/OQ/PQ documentation for packaging equipment.
• Coordinate protocol execution with Engineering, Quality, Operations, and vendors.
• Maintain validation documentation, URS, specs, change controls, SOPs, and records.
• Escalate risks or blockers promptly and manage multiple assignments.
• Perform work in compliance with GMP, data integrity, and site safety requirements.

Skills

IQ/OQ/PQ protocols

Technical writing

GMP compliance

Data integrity

Stakeholder coordination

Excel & Word

Education

Bachelor’s degree in engineering or science

Tools

Microsoft Word

Microsoft Excel

Job description

Validation & Engineering Group, Inc. in Allentown is seeking a Validation Specialist to support qualification of packaging equipment. The role focuses on developing, executing, reviewing, and closing IQ/OQ/PQ protocols with strong GMP and data integrity practices.

The ideal candidate has 5+ years of cGMP equipment validation experience, excellent technical writing skills, and the ability to coordinate with Quality, Engineering, and Operations to protect schedules and quality.