Senior Validation Engineer - GMP Process & Equipment Lead

Piper Companies; Durham (NC); Presencial; USD 96.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Dental benefits

Vision benefits

401(k)

Descripción de la vacante

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing client. This role focuses on validation activities in a regulated GMP environment, supporting fill/finish operations, equipment qualification, process validation, and compliance initiatives.

The Senior Validation Engineer will drive validation strategy, execution, investigations, and change management across critical systems.

Formación

• Bachelor's degree in Engineering, CS, or related field.
• 7+ years of validation, quality, or related pharma/medical device experience.
• Strong GMP knowledge and validation lifecycle experience.
• Experience with 21 CFR Part 11, GAMP5, ISO, FDA and ICH guidelines.
• Ability to author and review technical documentation and lead investigations.

Responsabilidades

• Provide validation support through IQ/OQ/PQ protocols, data analysis and reporting.
• Own Change Requests related to validation activities and deliverables.
• Author and review Validation Plans, PQMPs, protocols and reports.
• Execute validation activities for critical systems, equipment, and processes.
• Perform compliance reviews and technical approvals of validation data.
• Lead validation investigations and non-conformances using root cause analysis.
• Ensure validation activities comply with regulatory requirements.
• Create and revise validation procedures, CILs, specs and SOPs.
• Support FAT, SAT, commissioning, qualification and startup activities.
• Identify improvements and provide contractor oversight and budget support.

Conocimientos

Validation expertise

Project leadership

GxP knowledge

Root cause analysis

Documentation skills

Educación

Bachelor's degree in Engineering/CS

Master's degree preferred

Herramientas

Validation tools suite

Descripción del empleo

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing client. This role focuses on validation activities in a regulated GMP environment, supporting fill/finish operations, equipment qualification, process validation, and compliance initiatives.

The Senior Validation Engineer will drive validation strategy, execution, investigations, and change management across critical systems.