VHP Validation Engineer — GMP Biodecontamination Expert

ProQuality Network; Indianapolis (IN); On-site; USD 85,000 - 125,000; Full time

Job summary

ProQuality Network in Indianapolis, Indiana seeks a VHP Validation Engineer/Specialist to plan, execute, and document qualification and validation activities for Vaporized Hydrogen Peroxide systems used in regulated pharmaceutical environments. The role ensures GMP compliance and collaborates with Engineering, Manufacturing, QA, Microbiology, and vendors.

Responsibilities include developing validation strategies, IQ/OQ/PQ protocols, calibration verification, change control support, and guidance

Qualifications

• 3+ years in pharmaceutical/biotech/regulated manufacturing with equipment or process validation.
• Demonstrated experience with VHP/H2O2 biodecontamination systems and validation activities.
• Strong GMP principles and equipment qualification/validation methodologies.
• Experience with IQ/OQ/PQ protocols and reports.
• Experience with risk assessments, deviations, CAPA, and change controls.
• Experience working with controlled documentation in a regulated environment.

Responsibilities

• Develop and execute validation/qualification activities for VHP generators, decontamination systems, chambers, pass-throughs, isolators, and related equipment.
• Develop URS, risk assessments, DQ/IQ/OQ/PQ, and other qualification documents.
• Develop VHP cycle development and validation strategies and evaluate critical instruments calibration.
• Support change control, deviation, CAPA, and periodic reviews of validated systems.
• Provide technical guidance on VHP cycle optimization and equipment performance.

Skills

VHP/biodecontamination validation

Equipment qualification

IQ/OQ/PQ

Cycle development

GMP documentation

Risk assessment

Deviation/CAPA investigation

Technical writing

Education

Bachelor's degree in Engineering, Microbiology, Pharmaceutical Sciences, Chemistry, or related discipline

Job description

ProQuality Network in Indianapolis, Indiana seeks a VHP Validation Engineer/Specialist to plan, execute, and document qualification and validation activities for Vaporized Hydrogen Peroxide systems used in regulated pharmaceutical environments. The role ensures GMP compliance and collaborates with Engineering, Manufacturing, QA, Microbiology, and vendors.

Responsibilities include developing validation strategies, IQ/OQ/PQ protocols, calibration verification, change control support, and guidance