Manufacturing Technical Support Specialist / Deviations SpecialistLocation: Madison, WI – 100% Onsite
Duration: 2+ Year Contract
Openings: 9
Hours: 40+ hours/week, occasional OT
Start Date: ASAPJob DescriptionWe 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.ResponsibilitiesProvide 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 QualificationsAssociate'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.