Senior Leadership Role for Process Equipment and Validation
This is a senior leadership position that oversees the lifecycle of process equipment and validation at our Dundalk site.
Main Responsibilities:
* Serving on the Engineering Leadership Team, contributing to site strategy, operational planning, and cross-functional decision-making.
* Defining and executing the Process Equipment & Validation strategy, aligned with corporate and global engineering standards.
* Providing leadership to embed a compliance-first, customer-focused, delivery-driven culture and integrate engineering deliverables into commercial manufacturing operations.
* Ensuring technical and compliance governance for validated systems including process equipment, cleanrooms, utilities, laboratory systems, cleaning validation, thermal mapping, and computerized systems.
Requirements:
* A proven track record of establishing, developing, and scaling Process Engineering/Validation functions in greenfield or large-scale biotech environments.
* Expertise in process equipment and validation lifecycle management within a cGMP-regulated biotech/biologics environment.
* Knowledge of biotechnology manufacturing operations, large-scale unit operations, validation standards, and global regulatory requirements.