Principal Validation Engineer

About the role

Amgen is hiring a Principal Validation Engineer in Singapore to work with its global quality teams, manufacturing sites and contract manufacturing organizations (CMOs) to ensure the supply of high-quality product made at contract manufacturers. The role oversees validation strategies and documents mainly for Synthetic Drug Substance (API) and Biologic Aseptically Filled Drug Product, and sits on the core tech transfer team. The CMO sites are primarily in the JAPAC region (China, India, Japan), with occasional support in Europe or North America, and occasional travel to those sites.

Key responsibilities

• Act as a quality member of cross-functional CMO teams covering operations, analytical science, process development and supply chain, translating Amgen requirements into CMO terms and assessing validation and quality risks.
• Oversee synthetic API and biologic DP process and cleaning validation, and aseptic processing and sterilization validation (media fill, autoclave, EM).
• Oversight of packaging qualification and device and combination product qualification, including defining sample plans and acceptance criteria.
• Author and approve validation documents, review and approve master batch records and deviations, and prepare audit and inspection materials.
• Write validation sections of marketing applications and respond to regulatory questions.
• Perform validation change control assessments and drive operational excellence.

Required profile

• Doctorate with 2 years, or Master's with 6 years, or Bachelor's with 8 years of directly related experience.
• Prior experience as validation lead for NPI or tech transfer, and experience validating synthetic drug substance and aseptic drug product manufacturing.
• At least 6 years in a cGMP manufacturing environment with a strong understanding of regulatory requirements.
• Experience resolving complex deviations and designing or improving processes conceptually.

Required skills

• Cleaning validation and aseptic process simulation.
• Process and cleaning validation, qualification of finished drug product and packaging, and tech transfer.
• Statistical methods for risk-based sampling plans and acceptance criteria.
• Strong analytical, troubleshooting, communication and presentation skills, and ability to work with global, virtual teams.