Validation Engineer

Baanyan Software Services, Inc.

Cranbury · On-site Full-time Yesterday

About the role

About the Role

We’re seeking a PPQ & Process Validation Engineer to support regulated biotech operations involving plant‑based materials and biologics. This role ensures all PPQ‑regulated workflows, material handling steps, and treatment processes are validated, compliant, and scientifically sound.

Responsibilities

Oversee PPQ compliance for plant‑derived raw materials, seeds, tissues, or biologics used in R&D and GMP manufacturing
Manage permits, certificates, and USDA/APHIS documentation for regulated materials
Lead IQ/OQ/PQ validation for equipment and processes tied to PPQ workflows
Validate treatment, sterilization, inspection, and sampling processes
Conduct risk assessments (FMEA, 5‑Why) and support CAPA for deviations
Partner with QA, Regulatory, Manufacturing, and R&D to embed PPQ controls into operations
Train teams on validated processes and PPQ requirements

Qualifications

Degree in Engineering, Biotechnology, Plant Science, or related field
Experience in GMP/GxP process validation or regulated biotech manufacturing
Understanding of USDA/APHIS PPQ regulations
Strong documentation, analysis, and problem‑solving skills
Experience with plant‑based biologics or agricultural biotech is a plus

Requirements

Degree in Engineering, Biotechnology, Plant Science, or related field
Experience in GMP/GxP process validation or regulated biotech manufacturing
Understanding of USDA/APHIS PPQ regulations
Strong documentation, analysis, and problem‑solving skills

Responsibilities

We’re seeking a PPQ & Process Validation Engineer to support regulated biotech operations involving plant‑based materials and biologics
This role ensures all PPQ‑regulated workflows, material handling steps, and treatment processes are validated, compliant, and scientifically sound
Oversee PPQ compliance for plant‑derived raw materials, seeds, tissues, or biologics used in R&D and GMP manufacturing
Manage permits, certificates, and USDA/APHIS documentation for regulated materials
Lead IQ/OQ/PQ validation for equipment and processes tied to PPQ workflows
Validate treatment, sterilization, inspection, and sampling processes
Conduct risk assessments (FMEA, 5‑Why) and support CAPA for deviations
Partner with QA, Regulatory, Manufacturing, and R&D to embed PPQ controls into operations
Train teams on validated processes and PPQ requirements

Skills

5-WhyCAPAFMEAGMPGxPIQ/OQ/PQPPQUSDA/APHIS

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