Tech Transfer Process Engineer

Tech Transfer Process EngineerLocation: (WA)Position OverviewThe client is seeking an experienced Tech Transfer Process Engineer to support New Product Introduction (NPI) and technical transfer activities within a sterile, aseptic fill-finish manufacturing environment. The role will focus primarily on transferring incoming client products and processes to the site, developing process controls, coordinating transfer activities, and supporting process development and validation.The engineer will work closely with clients and cross-functional teams to ensure successful technical turnover and manufacturing readiness. Responsibilities will include developing and authoring transfer plans, process control strategies, protocols, risk assessments, and technical reports.Key ResponsibilitiesLead and support NPI technical transfer activities for incoming client products.Review and assess product and process data to support successful technology transfer.Develop and author process control strategies, transfer plans, protocols, and technical documentation.Define and coordinate activities required for process development, site readiness, and process validation.Conduct risk assessments and identify potential process and manufacturing risks.Write and execute hands-on batch sampling protocols and study documentation.Collaborate directly with clients to understand requirements and resolve technical issues.Support change controls, deviations, investigations, and study closeout reports.Work closely with manufacturing and cross-functional teams in a hands-on capacity on the manufacturing floor.Ensure technical transfer activities are completed efficiently and in accordance with applicable GMP requirements.Required Background & Skills8–10 years of pharmaceutical industry experience.Experience working within a CDMO environment, preferably in a fast-paced setting.Strong experience with aseptic/sterile manufacturing and fill-finish operations.Hands-on experience working directly on or around manufacturing lines.Proven experience with NPI and technical transfer activities.Experience with process development, validation, risk assessments, protocols, deviations, and change controls.Strong technical writing and documentation skills.Ability to work directly with clients and effectively communicate technical information.Soft SkillsConfident and professional client-facing communication.Highly organized and able to manage multiple priorities.Collaborative and comfortable working in a fast-paced environment.Hands-on approach with a willingness to work directly on the manufacturing floor.Strong problem-solving and communication skills.