Manufacturing Technical Support Specialist

Job Title: Manufacturing Technical Support Specialist

Location: Madison, WI

Job Summary:

Seeking a Manufacturing Technical Support/Deviations Specialist to support
GMP biologics manufacturing through technical troubleshooting, deviation investigations, documentation, and process improvements.

Key Responsibilities:


- Provide real-time manufacturing troubleshooting and technical support.
- Manage deviations, CAPA, change controls, and root-cause investigations.
- Prepare SOPs, batch records, reports, and GMP documentation.
- Analyze process data and identify trends/issues.
- Support process, equipment, and continuous improvement projects.
- Assist with technology transfer, scale-up, and process qualification.
- Work with Manufacturing, QA, QC, Engineering, and Process Development teams.
- Support client meetings and technical presentations.


Required Experience:


- 3–4+ years of relevant experience with a Bachelor’s degree in STEM, or equivalent education/experience.
- Experience in GMP biologics/pharmaceutical manufacturing.
- Hands-on experience with process equipment and troubleshooting.
- Experience with deviations, CAPA, RCA, and change controls.
- Knowledge of upstream/downstream processing, cell culture, chromatography, TFF, or filtration.
- Strong technical writing, data analysis, and problem-solving skills.
- Experience with technology transfer and cleanroom/cGMP operations preferred.