Validation Engineer
Listed on 2026-10-05
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Engineering
Quality Engineering, Regulatory Compliance Specialist, Pharma Engineer -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
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.
- 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.
- 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.
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.
-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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