Validation Engineer - 176116

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

Benefits offered by this job

Medical benefits

401K

Sick leave as required by law

Job summary

Piper Companies seeks a Validation Engineer for a long-term onsite contract in Clayton, NC, to support validation work across manufacturing, facilities, lab, automation, and quality systems while maintaining GMP/FDA compliance.

Ideal candidate brings 5+ years in pharma validation, hands-on IQ/OQ/PQ, and experience with SCADA, PLCs, PAS-X, LMES, Veeva, and HP ALM/TIMS in regulated settings.

Qualifications

• 5+ years of validation experience in pharma or regulated manufacturing.
• Hands-on with manufacturing equipment, aseptic processing, packaging, labs, utilities or facilities.
• Knowledge of computerized systems validation and familiar with stated platforms.
• Experience authoring qualification protocols and validation reports.
• Bachelor’s degree in Engineering, Life Sciences, Computer Systems or related field.

Responsibilities

• Develop, revise, and maintain validation lifecycle docs (validation plans, specs, risk assessments, traceability, reports, change control).
• Author and execute IQ, OQ, PQ, design reviews, commissioning support, and process validation.
• Partner with project managers, engineering, QA, and vendors for equipment upgrades and facility mods.
• Investigate deviations, assess validation impact, document corrective actions, support change management.
• Ensure all validation deliverables meet GMP and FDA, GAMP5, Annex 15, and internal procedures.

Skills

Validation experience

GMP knowledge

Regulated manufacturing

Deviation management

Education

Bachelor’s degree in Engineering

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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