Sterile Validation Engineer: GMP & FAT/SAT Lead

Amneal Pharmaceuticals; Town of Brookhaven (NY); On-site; USD 82,000 - 110,000; Full time

Job summary

Amneal Pharmaceuticals in the United States seeks a Validation Engineer, Sterile, to lead validation and qualification activities for manufacturing and packaging equipment in a sterile GMP environment. You will prepare FAT/SAT, IQ/OQ, PQ, and requalification protocols and ensure documentation meets cGMP standards and site procedures.

You will coordinate with Engineering, Manufacturing, and Quality, track deliverables, support change control and CAPA, and help develop SOPs and training to sustain

Qualifications

• Bachelor's degree in Engineering, life sciences, pharmaceutical sciences, or related field.
• Master's degree in Engineering, life sciences, pharmaceutical sciences, or related field preferred.
• 2+ years in Validation or qualification experience in GMP-regulated pharma/biotech environment.
• 2+ years in sterile or aseptic manufacturing environment.

Responsibilities

• Prepares and revises validation plans, protocols, reports, traceability matrices, risk assessments, and supporting documents for assigned equipment and systems.
• Executes and documents FAT, SAT, IQ, OQ, PQ, and requalification for manufacturing and packaging equipment, facilities, and utilities.
• Supports commissioning, equipment installation, startup, and turnover to operations; coordinates test execution with cross-functional teams.
• Drafts and revises SOPs and work instructions; initiates change controls and validation impact assessments; participates in CAPA investigations.
• Maintains validation records per cGMP and GDP; supports audits and inspections.

Skills

GMP validation

Protocol execution

Technical writing

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering or life sciences

Master's degree preferred

Tools

Microsoft Office

Electronic quality systems

Technical drawing review

Job description

Amneal Pharmaceuticals in the United States seeks a Validation Engineer, Sterile, to lead validation and qualification activities for manufacturing and packaging equipment in a sterile GMP environment. You will prepare FAT/SAT, IQ/OQ, PQ, and requalification protocols and ensure documentation meets cGMP standards and site procedures.

You will coordinate with Engineering, Manufacturing, and Quality, track deliverables, support change control and CAPA, and help develop SOPs and training to sustain