Validation Engineer - 175499

Zp Group Llc

  • Clayton, NC
  • 2 days ago
  • $71–$81 Per Hour

Highlights

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. · Partner with project managers, engineering teams, quality personnel, and vendors to support equipment upgrades, facility modifications, automation initiatives, and technology modernization efforts.

Numbers & Facts

LocationClayton, NC
Salary$71–$81 Per Hour

Description

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.

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