Onsite Validation Engineer (CQV) – GMP Facilities

Piper Companies; Clayton (NC); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

PTO

Paid holidays

Job summary

Piper Companies seeks a Validation Engineer for a leading pharmaceutical manufacturer in Clayton, NC. The role requires full onsite work in Clayton and targets a seasoned professional with CQV experience across GMP environments, facility systems, and QC laboratories.

Responsibilities include leading CQV activities, developing IQ/OQ/PQ docs, and ensuring compliance with FDA/EU GMP standards. A 2-year contract with potential extensions is offered.

Qualifications

• 5+ years of validation experience in regulated environments.
• Hands-on CQV for facility systems, manufacturing processes, or computerized systems.
• Knowledge of aseptic processing, filling, packaging, warehouse validation, or QC lab validation.
• Familiarity with cGMP, FDA guidance, GAMP 5, and data integrity.
• Bachelor's degree in a technical discipline.

Responsibilities

• Lead CQV activities for facility systems, equipment, and utilities in GMP operations.
• Develop, execute, and review IQ/OQ/PQ protocols and validation plans.
• Support validation efforts across aseptic formulation, filling, packaging, and labs.
• Collaborate with engineering, QA, manufacturing, IT, and operations to meet timelines.
• Investigate deviations, implement corrective actions, ensure regulatory compliance.

Skills

Validation expertise

GMP compliance

Cross-functional

Regulatory knowledge

Problem solving

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science, or related

Tools

CQV methodologies

IQ/OQ/PQ protocols

Data integrity knowledge

Job description

Piper Companies seeks a Validation Engineer for a leading pharmaceutical manufacturer in Clayton, NC. The role requires full onsite work in Clayton and targets a seasoned professional with CQV experience across GMP environments, facility systems, and QC laboratories.

Responsibilities include leading CQV activities, developing IQ/OQ/PQ docs, and ensuring compliance with FDA/EU GMP standards. A 2-year contract with potential extensions is offered.