Validation Engineer

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

Benefits offered by this job

Comprehensive benefits

Job summary

Piper Companies seeks a Validation Engineer to support GMP-regulated operations at a Clayton, NC site. You will lead CQV activities for facility systems, equipment, and utilities in a fully onsite role.

The role requires 5+ years CQV experience, knowledge of aseptic processing, FDA guidance, and collaboration with engineering, quality, IT, and manufacturing to meet regulatory timelines and quality objectives. A Bachelor's in engineering or life sciences is required.

Qualifications

• 5+ years of validation experience in regulated manufacturing.
• Bachelor's degree in Engineering, Life Sciences, or related field.
• Experience with CQV projects for facility systems or processes.
• Knowledge of aseptic processing and QC laboratories.

Responsibilities

• Lead commissioning, qualification, and validation for facility systems and equipment.
• Develop, execute, and review IQ/OQ/PQ protocols and validation plans.
• Support validation across aseptic formulations, filling, packaging, and labs.
• Collaborate with engineering, QA, manufacturing, IT to meet timelines.
• Investigate deviations and ensure FDA/EU-GMP compliance.

Skills

CQV experience

GMP knowledge

Cross-functional collaboration

FDA guidance familiarity

Aseptic processing understanding

Education

Bachelor's degree in Engineering / Life Sciences / Computer Science

Tools

CQV documentation tools

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 10/02/2026. 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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