Pharma Validation Engineer: GMP & Compliance

Insight Global; Clayton (NC); Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

Insight Global is seeking a Validation Engineer to support a growing portfolio of capital projects and manufacturing initiatives in pharmaceutical production. The role focuses on planning, authoring, executing, and reporting validation activities across systems, facilities, utilities, and automation, ensuring GMP compliance.

You will collaborate with Project Managers, Engineering, Automation, Operations, Quality, and Maintenance to deliver validated systems on time, manage documentation, and

Qualificações

• Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical discipline.
• 3+ years of validation experience in regulated pharma/biotech/medical device/GMP environments.
• Experience authoring and executing validation protocols and reports for DQ/IQ/OQ/PQ/PV.
• Familiarity with GMP, FDA guidance, EU Annex 15, and GAMP 5.
• Experience supporting equipment qualification, facility modifications, or manufacturing validation.
• Strong technical writing and documentation skills.
• Experience managing validation documentation across multiple projects.

Responsabilidades

• Develop, revise, and maintain validation lifecycle documentation per Novo Nordisk procedures and regulatory requirements.
• Author and execute validation deliverables: Plans, URS, FDS, Risk Assessments, and Traceability Matrices.
• Create and summarize DQ/IQ/OQ/PQ/PV; support FAT and SAT activities as needed.
• Track project documentation and provide status updates for initiatives.
• Collaborate with Engineering, Automation, Operations, Quality Assurance, and Maintenance to maintain validated systems.

Conhecimentos

Validation lifecycle documentation

Regulatory knowledge

Technical writing

Project management

Cross-functional collaboration

Formação académica

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

Ferramentas

HP ALM / eTIMS

Veeva

QualityDocs

Descrição da oferta de emprego

Insight Global is seeking a Validation Engineer to support a growing portfolio of capital projects and manufacturing initiatives in pharmaceutical production. The role focuses on planning, authoring, executing, and reporting validation activities across systems, facilities, utilities, and automation, ensuring GMP compliance.

You will collaborate with Project Managers, Engineering, Automation, Operations, Quality, and Maintenance to deliver validated systems on time, manage documentation, and