Manufacturing Engineer

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.

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.

All your information will be kept confidential according to EEO guidelines.