Lead Validation Engineer - GMP & Regulatory

International Association of Plumbing and Mechanical Officials (IAPMO); Allentown, Northern (Lehigh County, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

IAPMO is seeking a Quality Validation Engineer to lead validation activities across packaging, laboratory and utility systems in Allentown, PA. The role involves planning, executing, and documenting installation and qualification studies, ensuring regulatory compliance and coordination with process heads and engineering teams.

The ideal candidate will have 4+ years in validation or regulatory roles, a scientific/technical degree, strong project management skills and a meticulous attention to

Qualifications

• Bachelor’s degree or higher in relevant scientific/technical field.
• Total Combined Years: 4 or more years within industry or Regulatory/Compliance, including project management experience.
• Experience in project management.
• Well organized with keen attention to detail.
• Knowledge of the various state and federal pharmaceutical validation laws and legislations.

Responsibilities

• Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility systems.
• Schedules, plans, manages and executes studies for cleaning validation.
• Schedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocol.
• Reviews and approves validation project documentation.
• Coordinates with process unit heads, quality and engineering groups to ensure successful project execution.
• Leads and coordinates cross-functional teams for project validation.

Skills

cGMP & regulatory compliance

professional communication

computer literacy

collaboration

project management

Education

Bachelor's degree or higher in a scientific/technical field

Tools

Microsoft Outlook

Excel

Word

Job description

IAPMO is seeking a Quality Validation Engineer to lead validation activities across packaging, laboratory and utility systems in Allentown, PA. The role involves planning, executing, and documenting installation and qualification studies, ensuring regulatory compliance and coordination with process heads and engineering teams.

The ideal candidate will have 4+ years in validation or regulatory roles, a scientific/technical degree, strong project management skills and a meticulous attention to