Validation Engineer - 175499

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

Job summary

Piper Companies is seeking a Validation Engineer to join a leading pharmaceutical manufacturing organization for a long-term onsite contract in Clayton, NC. The role focuses on diverse project work across manufacturing, facilities, laboratory, automation, and quality systems.

The engineer will ensure compliance with GMP, FDA regulations, GAMP 5, and Annex 15 while delivering robust validation activities and documentation. This onsite position supports a regulated environment.

Qualifications

• 5+ years of validation experience in pharmaceutical, biotech, or regulated manufacturing.
• Hands-on validation for equipment, aseptic processing, packaging, lab, utilities, or facilities.
• Knowledge of computerized systems validation; familiarity with SCADA, PLCs, PAS-X, LMES, Veeva, HP ALM/TIMS.
• Experience authoring/ executing qualification protocols, validation reports, risk assessments, and electronic validation docs.
• Bachelor’s degree in Engineering, Life Sciences, Computer Systems, or related technical field.

Responsibilities

• Develop, revise, and maintain validation lifecycle docs (plans, specs, risk assessments, traceability, reports).
• Author and execute IQ/OQ/PQ, design reviews, commissioning support, and process validation.
• Partner with PMs, engineering, quality, and vendors for upgrades and automation initiatives.
• Investigate deviations, assess impacts, document corrective actions, and support change control.
• Ensure validation deliverables meet GMP and FDA requirements; align with GAMP 5 and Annex 15.

Skills

Validation experience

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical discipline

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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