Associate Director, Engineering

Company: Merck

Job Overview

Serves as the site engineering lead for the startup of a pharmaceutical filling and lyophilization facility. Responsibilities include leading commissioning, qualification, and validation of equipment and systems, ensuring regulatory compliance (USDA, FDA), and overseeing aseptic manufacturing operations.

Responsibilities:

• Lead commissioning, qualification, and validation of equipment and systems.
• Ensure regulatory compliance (USDA, FDA).
• Oversee aseptic manufacturing operations.
• Build and manage an engineering team.
• Develop maintenance strategies.
• Troubleshooting.

Requirements:

• Bachelor's degree in engineering (MBA/Master's preferred).
• 8-10 years of experience in construction, plant engineering, people management, and capital projects.
• Experience preferably in a regulated manufacturing environment.