Fill Finish and Packaging Engineer

Fill Finish & Packaging EngineerPLEASE NOTE WE DO NOT WORK ON C2C BASISOpen to Candidates with citizenship from the US and CanadaADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.This is an outstanding opportunity to join our growing team!Role SummaryWe're seeking an experienced and hands-on engineering professional to support the design, implementation, and documentation of equipment and processes for automated syringe assembly and packaging. This position will contribute to cross-functional technical transfer initiatives, process optimization, and documentation development in a regulated environment.Documentation & SOP DevelopmentAuthor and revise SOPs for flexible operating parameters and process requirementsDraft SOPs and six Work Instructions (WIs) for recipe developmentUpdate Engineering Equipment Assessment SOPs to ensure alignment with process requirementsPerform technical writing tasks including regulatory document reviews, specifications, and training content creationOperational & Material CoordinationSupport onboarding of materials and vendors into relevant systemsCoordinate material movement and inventory management activities with Procurement, Warehouse, and OperationsPrepare and process move order requests and onboarding documentationQualifications & SkillsBachelor's degree in engineering or a related technical field (preferred)Min 3 years' experience in regulated manufacturing environments (e.g., pharmaceutical, biotech, medical devices)Proficiency in SOP development and technical writingStrong data analysis and cross-functional collaboration skillsFamiliarity with equipment qualification, process validation, and packaging automation

Created: 2025-10-01