Senior Sterile Process Engineer: Scale-Up, Validation & GMP

Merck & Co.; Town of Brookhaven (NY); On-site; USD 110,000 - 125,000; Full time

Job summary

Amneal is seeking a Senior Process Engineer in sterile manufacturing to drive transfers from concept to launch, scale-up, and aseptic simulation. You will lead improvement initiatives and support process deviations, acting as SME for sterile/aseptic filling, packaging, and related operations.

The role requires strong GMP/cGMP knowledge, project management, and collaborative skills to coordinate with R&D, Manufacturing, and QA.

Qualifications

• BS in Engineering required; MS preferred.
• Experience in GMP/sterile manufacturing environments.
• Strong knowledge of FDA/cGMP regulations.
• Proven project management and leadership skills.
• Excellent communication and collaboration across teams.
• Ability to troubleshoot complex manufacturing processes and deviations.

Responsibilities

• Transfer and scale-up of processes from development to commercial production.
• Lead continuous improvement initiatives and CAPA investigations.
• Provide SME support for sterile/aseptic filling, lyophilization, and depyrogenation.
• Develop/revise SOPs, validation plans, and change controls.
• Mentor training and ensure compliance with safety, quality, and environmental standards.

Skills

FDA compliance

cGMP knowledge

Project management

Root cause analysis

Leadership

Problem solving

Communication

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

P&ID

Engineering drawings

Data analysis software

Job description

Amneal is seeking a Senior Process Engineer in sterile manufacturing to drive transfers from concept to launch, scale-up, and aseptic simulation. You will lead improvement initiatives and support process deviations, acting as SME for sterile/aseptic filling, packaging, and related operations.

The role requires strong GMP/cGMP knowledge, project management, and collaborative skills to coordinate with R&D, Manufacturing, and QA.