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Manufacturing EngineerTechtrueup • Madison, Wisconsin, United States
Manufacturing Engineer

Manufacturing Engineer

Techtrueup • Madison, Wisconsin, United States
8 hours ago
Job type
  • Full-time
Job description

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.

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Manufacturing Engineer • Madison, Wisconsin, United States

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