Associate Director, Engineering
Palo Alto, Santa Clara County, California, 94306, USA
Listed on 2026-10-06
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Pharmaceutical
Regulatory Compliance Specialist, Validation Engineer
Associate Director, Engineering for Biologics External Manufacturing Technology, leading technical transfers and supply continuity for biologics products with external partners.
Responsibilitiesserve as the main technical interface, oversee tech transfer execution, ensure compliance, risk management, and process optimization across biologics modalities, and support validation, change management, investigations, and inspection readiness. Collaborates with cross-functional teams including Quality, Regulatory, Procurement, and Operations, managing complex external partner relationships and ensuring timely, within-budget technology transfers.
RequirementsBachelor's in Engineering or Science; 8+ years in biologics or vaccine manufacturing, process sciences, or engineering; expertise in technical transfer, process troubleshooting, and lean manufacturing; proven leadership and cross-functional team support.
Preferredadvanced degree, experience with large molecule biologics, international matrix environments, and continuous improvement methodologies.
High-Valuebiologics (large molecules), vaccine/biologics manufacturing, process transfer, risk mitigation, validation strategy, external partnership, US-based with 30-50% travel, hybrid or remote work options.
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