Associate Director, Engineering

Merck · Wilmington (biotech), DE

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OtherFull-time$142k–$224kCompany career page

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Role summary

Merck seeks an Associate Director of Technical Operations and Validation Lead for a new antibody drug conjugate manufacturing facility in Wilmington, Delaware. The role involves establishing and maintaining validation across drug substance and drug product manufacturing, leading the site validation organization from design through commercial operations, and ensuring regulatory compliance.

What they're looking for

Bachelor's degree in engineering, science, or related discipline
10+ years in validation, engineering, or technical operations within cGMP biologics or sterile pharmaceutical manufacturing
Start-up experience in large-scale commercial drug substance or drug product facility highly desirable
Experience with highly potent compounds, containment systems, isolator technologies, and ADC manufacturing strongly preferred
Demonstrated ability to lead matrix teams executing FAT, SAT, IQ/OQ, and engineering batches
Experience in aseptic process simulation, lyophilization, cleaning validation, and VHP processes highly desired

What you'll be doing

Build and lead the site validation organization, establishing governance, standards, and succession plans for startup and commercial operations
Partner with global validation centers of excellence to drive continuous improvements and ensure regulatory compliance
Lead engagement with engineering design firms on detailed design for drug substance and drug product manufacturing
Own validation master plan, continued process verification, cleaning validation, computer system validation, and lifecycle management of validated systems
Provide technical leadership during factory acceptance testing, site acceptance testing, engineering batches, and commercial manufacturing

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