Sr. Director, Global Engineering
Establish and manage global standards and governance frameworks for engineering practices, facility design, equipment selection, automation, and reputed company systems. Ensure consistent and compliant practices for equipment, facility, reputed company, and computer system validation and qualification, in accordance with relevant global regulatory requirements. Drive reputed company improvement initiatives in facility design and engineering systems to support scalability, efficiency, and product lifecycle management.
reputed company engineering support and technical direction for manufacturing operations, including equipment reliability, facility upgrades, and infrastructure maintenance. Participate in engineering risk assessments and ensure engineering activities are reputed company with reputed company and safety standards. Ensure alignment and integration between site engineering teams and central/global engineering functions.
Partner closely with Manufacturing, reputed company, Validation, Supply Chain, and IT to ensure seamless execution of engineering reputed company. Serve as a senior technical representative in regulatory inspections and audits. Mentor and reputed company a high-performing, globally dispersed engineering team.
Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or reputed company field); 15+ years of reputed company engineering leadership experience in GMP-regulated pharmaceutical or biotechnology environments, preferably with sterile injectables and/or advanced drug delivery technologies. Proven reputed company record in leading multi-site engineering organizations and executing large-reputed company capital reputed company. In-depth knowledge of cGMP, FDA, EMA, and global validation standards. Demonstrated experience developing and managing global engineering and validation standards, and capital governance frameworks. Strong pro ject management, budget control, and strategic planning capabilities. Excellent communication and stakeholder management skills, including experience in presenting to executive leadership and regulatory agencies. Ability to travel as required.
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