Filling Engineer – Aseptic Fill‑Finish Equipment (Remote + Travel)

About the role

We are a sterile pharmaceutical compounding company building a state‑of‑the‑art facility in Houston, Texas. The Filling Engineer will act as the technical liaison between equipment manufacturers in China/Singapore and our U.S. cGMP operation, ensuring that each fill‑finish line, lyophilizer, and utility system is qualified and ready for production.

Key responsibilities

• Identify, evaluate, and qualify equipment manufacturers for sterile fill‑finish, lyophilization, and utility equipment.
• Review equipment designs and specifications against U.S. cGMP and EU Annex 1 requirements.
• Plan, run, and witness Factory Acceptance Testing (FAT) at vendor sites and approve sign‑off only when specifications are met.
• Monitor build quality, manage punch‑list items, deviations, and corrective actions.
• Ensure complete English‑language documentation packages for FDA review.
• Manage spare‑parts strategy, packaging, and shipment logistics to the Houston site.
• Coordinate Site Acceptance Testing (SAT) and Installation/Operational Qualification (IQ/OQ) with the Houston commissioning team, traveling as needed.
• Provide ongoing technical support after equipment hand‑over.

Required profile

• Engineering background with experience in pharmaceutical or sterile manufacturing equipment.
• Familiarity with cGMP, FDA 21 CFR 210/211, and EU Annex 1 compliance.
• Proven ability to manage vendor relationships and conduct technical due diligence.
• Willingness to travel internationally and to the United States for installation and testing.

Required skills

• cGMP compliance
• Factory Acceptance Testing (FAT)
• Site Acceptance Testing (SAT)
• Installation Qualification (IQ) and Operational Qualification (OQ)
• Equipment specification review
• Technical documentation management
• Logistics and spare‑parts coordination

What we offer

• Opportunity to join an early‑stage, cutting‑edge sterile manufacturing project.
• Exposure to global equipment suppliers and U.S. regulatory environment.
• Travel opportunities and remote work flexibility.