Equipment Commissioning Engineer

该职位来源于猎聘 “英语流利（可与美国团队无障碍沟通）” / “Fluent English required — daily communication with US team.” We are a sterile pharmaceutical compounding company building a new, state-of-the-art manufacturing facility in Houston, Texas. The facility is being developed from a Class A shell into a dual-license operation that includes both a 503B Outsourcing Facility (operating under cGMP, 21 CFR 210/211) and a 503A sterile compounding pharmacy (operating under USP ＜797＞ / ＜800＞). Our product lines span sterile injectables, solid oral, and nasal dosage forms, including lyophilized formulations. We are assembling an experienced engineering and operations team to bring the facility online and operate it to the highest quality and compliance standards. This is an opportunity to join early and help build a modern sterile manufacturing operation from the ground up. (Specific product, capacity, and commercial details are shared with candidates under confidentiality during the interview process.) The Role We are procuring cGMP sterile manufacturing equipment — fill-finish lines, lyophilizers, depyrogenation tunnels, autoclaves, and water systems — from manufacturers for our new U.S. (Houston) facility. We need an engineer embedded with these factories who owns each machine from purchase order until it is proven working on the floor in Houston. Your accountability does not end when equipment passes Factory Acceptance Testing or leaves the dock — it runs through Site Acceptance Testing and IQ/OQ in the United States. You are the quality and technical layer between manufacturers and a U.S. cGMP operation, and the most important safeguard against equipment that 'passed FAT' but does not run in the U.S. Key Responsibilities Vendor Selection & Technical Due Diligence OEM vetting: Identify, evaluate, and qualify pharmaceutical-equipment manufacturers for sterile fill-finish, lyophilization, and utility equipment. Specification review: Review equipment design and specifications against U.S. cGMP and EU Annex 1 requirements — materials of construction, surface finishes, sterilization, automation, and contamination control — before purchase. Factory Acceptance & Build Quality FAT execution: Plan, run, and witness Factory Acceptance Testing at vendor sites. Do not approve sign-off until equipment genuinely performs to specification and documented requirements. Build oversight: Monitor build quality throughout fabrication; track and close out punch-list items, deviations, and corrective actions with the vendor. Documentation: Ensure complete, accurate, English-language documentation packages (drawings, manuals, materials certificates, test records) suitable for U.S. qualification and FDA review. Logistics & U.S. Hand-off Shipment & spares: Manage spare-parts strategy, packaging, and shipment logistics to the U.S. site. SAT / IQ-OQ coordination: Coordinate closely with the U.S. (Houston) commissioning team so each machine passes Site Acceptance Testing and IQ/OQ; travel to Houston as needed to support installation and startup. Continuous support: Serve as the ongoing liaison to vendors for warranty, technical support, parts, and future equipment orders. Required Qualifications Bachelor's degree in Engineering, Pharmaceutical Sciences, Mechanical/Electrical, Automation, or a related field 5+ years of experience with pharmaceutical sterile manufacturing equipment — aseptic fill-finish, lyophilizers, and/or critical utilities Hands-on experience planning and executing Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) Strong knowledge of GMP equipment documentation and qualification expectations Fluent Mandarin and English — the communication layer between manufacturers and a U.S. cGMP operation Willingness to travel frequently to vendor sites within China and regularly to the U.S. Preferred Qualifications Strongly preferred: a current U.S. visa (e.g., B-1/B-2 or other) or other status that allows easy, repeated travel to the United States. Candidates who can readily travel to our Houston site will be prioritized. Direct experience at or with major equipment OEMs (e.g., Tofflon / 东富龙, Truking / 楚天科技, Bosch/Syntegon) or a sterile CDMO Aseptic fill-finish (vial washing, filling, stoppering, capping) and/or lyophilization commissioning experience Knowledge of U.S. import requirements, EU Annex 1, ISO 14644, and contamination control strategy Experience with isolator/RABS systems, autoclaves, depyrogenation tunnels, and WFI/clean steam systems Supplier quality / supplier corrective action (SCAR) experience What We Offer A pivotal role connecting leading pharmaceutical-equipment manufacturers with a new U.S. sterile facility Travel coverage for vendor-site and U.S. travel Long-term scope as the facility grows We are looking for candidates with 5+ years in aseptic fill-finish or critical utilities and genuine English fluency, ideally from major OEMs or MNCs.