Validation Engineer - 175655

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 is seeking a Validation Engineer for a leading pharmaceutical manufacturing organization in Clayton, NC. The Validation Engineer role requires working fully onsite in Clayton, NC. The Validation Engineer role is ideal for an experienced validation professional with expertise supporting GMP-regulated environments across manufacturing operations, facility systems, quality control laboratories, and computerized systems.

Responsibilities of the Validation Engineer include:

• Lead commissioning, qualification, and validation activities for facility systems, manufacturing equipment, and supporting utilities within GMP-regulated operations.
• Develop, execute, and review validation documentation including IQ/OQ/PQ protocols, validation plans, risk assessments, and final summary reports.
• Support validation efforts across aseptic formulation and filling, device assembly and packaging, warehouse operations, QC laboratories, and computerized systems.
• Partner with engineering, quality assurance, manufacturing, IT, and operations teams to ensure validation deliverables meet project timelines and regulatory expectations.
• Investigate protocol deviations, implement corrective actions, and maintain compliance with FDA, EU GMP, and industry validation standards.

Requirements of the Validation Engineer include:

• 5+ years of validation experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Hands‑on experience supporting commissioning, qualification, and validation (CQV) projects for facility systems, manufacturing processes, or computerized systems.
• Knowledge of aseptic processing, filling operations, packaging systems, warehouse validation, and/or QC laboratory validation.
• Familiarity with cGMP regulations, FDA guidance, GAMP 5, and data integrity requirements.
• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.

Compensation for the Validation Engineer include:

• $130,000 - $160,000 annually
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.
• 2-year contract engagement with potential extension opportunities.
• This job opens for applications on 10/9/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: validation engineer, CQV engineer, commissioning engineer, qualification engineer, aseptic manufacturing, GMP, facility systems, IT systems validation, computer systems validation, CSV, QC validation, warehouse validation, packaging validation, pharmaceutical manufacturing

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