Manufacturing Engineer

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

• Associates Bachelors or Masters 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.

Remote Work :

No

Employment Type :

Contract