Validation Engineer - 175499

Piper Companies; Clayton (NC); On-site; USD 98,000 - 112,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K

Job summary

Piper Companies is seeking a Validation Engineer for a long-term onsite contract based in Clayton, NC. The role supports a diverse project portfolio across manufacturing, facilities, laboratory, automation, and quality systems while ensuring GMP compliance and FDA-aligned validation practices.

Responsibilities include IQ/OQ/PQ execution, documentation, change control, and collaboration with cross-functional teams to upgrade equipment, facilities, and automation systems.

Qualifications

• Experience in validation within pharmaceutical manufacturing or regulated environments.
• Ability to author and execute IQ/OQ/PQ and related validation documents.
• Familiarity with computerized systems validation and associated platforms.

Responsibilities

• Develop, revise, and maintain validation lifecycle documentation (validation plans, specifications, risk assessments, traceability matrices, reports, change controls).
• Author and execute qualification activities (IQ/OQ/PQ, design reviews, commissioning support, process validation).
• Collaborate with project managers, engineering, quality to support upgrades and modernization.
• Investigate deviations, assess impacts, document corrective actions, support change management.
• Ensure validation deliverables meet GMP and FDA regulatory requirements and GAMP 5, Annex 15.

Skills

Validation experience

GMP compliance

FDA regulations

Risk assessment

Documentation & change control

Qualification protocols

Qualification execution

Education

Bachelor’s degree in Engineering/Life Sciences/Computer Systems

Tools

SCADA

PLCs

PAS-X

LMES

Veeva

HP ALM/TIMS

Job description

Piper Companies is seeking a Validation Engineer to join a leading pharmaceutical manufacturing organization for a long-term onsite contract opportunity based in Clayton, NC. The Validation Engineer will support a diverse project portfolio across manufacturing, facilities, laboratory, automation, and quality systems while ensuring compliance with regulated industry standards.

Responsibilities of the Validation Engineer include:

• Develop, revise, and maintain validation lifecycle documentation including validation plans, specifications, risk assessments, traceability matrices, reports, and change control records.
• Author and execute qualification and validation activities such as IQ, OQ, PQ, design reviews, commissioning support, and process validation for manufacturing and facility-based projects.
• Partner with project managers, engineering teams, quality personnel, and vendors to support equipment upgrades, facility modifications, automation initiatives, and technology modernization efforts.
• Investigate deviations, assess validation impacts, document corrective actions, and support change management activities throughout project execution.
• Ensure all validation deliverables meet GMP requirements and align with FDA regulations, GAMP 5 principles, Annex 15 guidance, and internal quality procedures.

Qualifications for the Validation Engineer include:

• 5+ years of validation experience within a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Hands-on experience supporting manufacturing equipment, aseptic processing systems, packaging operations, laboratory environments, utilities, or facility infrastructure projects.
• Knowledge of computerized systems validation and familiarity with platforms such as SCADA, PLCs, PAS-X, LMES, Veeva, HP ALM/TIMS, or similar regulated systems.
• Experience authoring and executing qualification protocols, validation reports, risk assessments, and electronic validation documentation with minimal supervision.
• Bachelor’s degree in Engineering, Life Sciences, Computer Systems, or a related technical discipline.

Compensation for the Validation Engineer:

Salary Range: $71-$81/hr (USD)

Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 09/30/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: validation engineer, validation specialist, GMP, pharmaceutical manufacturing, biotechnology, commissioning, qualification, IQ, OQ, PQ, process validation, computerized systems validation, CSV, SCADA, PLC, PAS-X, LMES, Veeva, HP ALM, TIMS, FDA regulations, GAMP 5, Annex 15, aseptic manufacturing, filling equipment, RABS, packaging equipment, vision systems, laboratory validation, utilities, HVAC, BMS, calibration, instrumentation, change control, deviation management, project management, quality systems, engineering, production equipment, facility validation, risk assessment, traceability matrix.

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