Sterile Validation Engineer: GMP Equipment & Systems

Merck & Co.; Town of Brookhaven (NY); On-site; USD 82,000 - 110,000; Full time

Job summary

Amneal seeks a Validation Engineer, Sterile, in New York to support validation and qualification activities across manufacturing and packaging equipment, facilities, and systems in a sterile GMP environment.

You will prepare and execute FAT/SAT, IQ/OQ/PQ, requalification, and related documentation, coordinating with Engineering, Manufacturing, and Quality to ensure adherence to site procedures. Strong writing and cross-functional collaboration are essential.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• MS/MA in engineering, life sciences, or related field preferred.
• 2+ years in validation or qualification in a GMP-regulated environment.
• Experience in sterile or aseptic environments preferred.

Responsibilities

• Prepare and revise validation plans, protocols, and reports.
• Execute FAT/SAT, IQ/OQ/PQ and requalification activities.
• Coordinate with Engineering, Manufacturing, Quality, vendors, and contractors.
• Maintain validation records and support CAPAs and deviations.
• Assist with audits, inspections, and change controls.

Skills

Validation & QA

cGMP knowledge

Documentation

Cross-functional

Technical writing

Microsoft Office

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

Validation software

Microsoft Excel

Document management system

Job description

Amneal seeks a Validation Engineer, Sterile, in New York to support validation and qualification activities across manufacturing and packaging equipment, facilities, and systems in a sterile GMP environment.

You will prepare and execute FAT/SAT, IQ/OQ/PQ, requalification, and related documentation, coordinating with Engineering, Manufacturing, and Quality to ensure adherence to site procedures. Strong writing and cross-functional collaboration are essential.