Quality Validation Engineer – GMP/GxP & CAPA Lead (Onsite PA)

Pyramid Consulting, Inc; Swiftwater (Monroe County); On-site; USD 96,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid sick leave

Job summary

Pyramid Consulting, Inc. has an immediate need for a Quality Validation Engineer / Validation Specialist/Quality Manager III in Swiftwater, PA.

This 12+ month contract requires strong expertise in validation, CAPA, and regulatory compliance to support life sciences manufacturing. You will collaborate with Quality, Manufacturing, Engineering and Regulatory Affairs to ensure QSR/GxP adherence, lead CAPA investigations, and deliver robust technical documentation and reporting across equipment,

Qualifications

• Bachelor's degree in engineering, life sciences, or related technical discipline.
• 6–9 years in pharmaceutical, biopharmaceutical, or other regulated manufacturing.
• Strong background in quality validation, quality systems, and regulatory compliance.
• Experience leading CAPA investigations and activities.
• Knowledge of QSR, GxP requirements, and industry best practices.
• Experience supporting validation activities for equipment, processes, facilities, and computerized systems.

Responsibilities

• Lead CAPA investigations and activities.
• Support validation activities for equipment, processes, facilities, and computerised systems.
• Collaborate with Quality, Manufacturing, Engineering, Validation and Regulatory Affairs.
• Prepare and maintain technical documentation and reports.
• Ensure compliance with FDA, GMP, GxP, and QSR requirements.

Skills

Quality Validation

CAPA Management

Regulatory Knowledge

Cross-Functional Collaboration

Project Management

Technical Documentation

Continuous Improvement

Education

Bachelor's degree in Engineering/Life Sciences

Master's degree preferred

Job description

Pyramid Consulting, Inc. has an immediate need for a Quality Validation Engineer / Validation Specialist/Quality Manager III in Swiftwater, PA.

This 12+ month contract requires strong expertise in validation, CAPA, and regulatory compliance to support life sciences manufacturing. You will collaborate with Quality, Manufacturing, Engineering and Regulatory Affairs to ensure QSR/GxP adherence, lead CAPA investigations, and deliver robust technical documentation and reporting across equipment,