Melanie Tang

WORK HISTORY

EDUCATION

ABOUT MELANIE TANG

Hey there, I’m Melanie, a validation and operations professional with hands-on experience supporting GMP manufacturing, quality systems, and production readiness in regulated environments.I currently work in US Market Supply Chain Operations supporting isolator fill line readiness, where I develop and execute validation protocols, assess documentation for compliance, and partner closely with manufacturing, quality, and technical teams to ensure processes meet FDA, EMA, and internal quality standards.My background blends engineering execution with strong cross-functional coordination. I’m comfortable on the production floor, in SOPs and protocols, and in conversations that align operations, quality, and engineering to helping teams move efficiently without compromising compliance.What I bring to manufacturing & engineering teams: Validation experience (IQ/OQ/PQ, protocols, SOPs, VMPs, CPPs)🧪 GMP, QM/QD, FDA & EMA compliance mindset Strong documentation, deviation awareness, and audit readiness Collaboration with production, MS & T, quality, and engineering partners KPI-driven execution supporting throughput, readiness, and reliabilityWhere I add value: Supporting production and fill/finish operations🧩 Improving process clarity, handoffs, and documentation flow Ensuring validation and operational readiness without slowing execution Helping teams scale safely and consistentlyCareer focus: Manufacturing Engineer, Validation Engineer, Process Engineer, or Production Technician roles Especially interested in sterile manufacturing, fill/finish, and supply chain operations Continuing to build technical depth while growing long-term into technical leadership rolesOutside of work, I enjoy volunteering with Women in STEM, coordinating cultural initiatives, exploring food and photography, gaming, and unwinding with a good K-Drama Let’s connect—especially if you’re passionate about manufacturing excellence and patient impact.