Manufacturing Engineer at Techtrueup Madison, WI
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Over deze vacature
Fusion Life Sciences Technologies is a tech-oriented organization at the intersection of engineering excellence and workforce scalability. We partner with Fortune 500 clients to deliver contingent workforce solutions, project-based engineering services, and digital innovation that accelerate time-to-market, enhance compliance, and reduce cost. We believe that strong people build strong companies — and our work focuses on connecting skilled talent and technical capability to help clients deliver projects faster, improve operational performance, and maintain compliance in mission-critical environments. Job Description Manufacturing Technical Support Specialist / Deviations Specialist Location: Madison, WI – 100% Onsite Duration: 2+ Year Contract Openings: 9 Hours: 40+ hours/week, occasional OT Start Date: ASAP Job Description We are looking for Manufacturing Technical Support Specialists / Deviations Specialists to support clinical and commercial manufacturing operations in a cGMP environment . The role will provide real-time technical support, troubleshooting, deviation management, process improvement, and technical documentation support for biologics and molecular therapeutics manufacturing. Responsibilities Provide real-time technical troubleshooting and manufacturing floor support. Support deviations, CAPAs, change controls, investigations, and root-cause analysis . Review and prepare SOPs, batch production records, technical reports, and GMP documentation . Work with Manufacturing, Process Development, QA, QC, Supply Chain, Facilities, and other teams. Support technology transfer, facility fit, process scaling, and process implementation . Analyze process data, identify trends, and communicate technical findings. Identify opportunities for process and equipment improvements . Support continuous improvement and efficiency initiatives. Provide technical support during client meetings and presentations. Support biologics manufacturing processes across clinical and commercial production. Work with upstream, downstream, and/or molecular therapeutics processes . Provide technical guidance and support to manufacturing team members. Apply quality risk management tools such as FMEA and Hazard Analysis . Required Qualifications Associate's, Bachelor's, or Master's degree in a STEM discipline with relevant industry experience. Experience in a GMP/cGMP manufacturing environment . Experience with technical documentation, reporting, and data analysis. Experience writing and revising SOPs, batch records, and technical reports . Hands-on experience with process equipment and troubleshooting. Knowledge of deviations, CAPA, change controls, investigations, and root-cause analysis . Experience with technology transfer, process scaling, or facility fit . Knowledge of upstream mammalian cell culture and/or downstream purification processes . Experience with chromatography, TFF, filtration, buffer preparation, or bioreactors is preferred. Strong analytical, problem-solving, communication, and presentation skills. Proficiency with Microsoft Office, especially Excel and Word . Ability to work effectively in a cleanroom and fast-paced manufacturing environment. Additional Information All your information will be kept confidential according to EEO guidelines.