Primary Skills: Process Validation [Advanced], GMP Compliance [Advanced], CQV [Advanced], Equipment Troubleshooting [Advanced], Root Cause Analysis [Advanced],
Contract Type: W2
Duration: 6 Months
Location: New Albany OH (Onsite)
Pay Range: $45.00 - $55.00 Per Hour
Job Summary:This role is crucial for ensuring the smooth operation of commercial manufacturing by leading the development and validation of automated assembly and packaging processes. You will leverage your engineering expertise to troubleshoot issues, optimize critical parameters, and drive continuous improvement initiatives. Your responsibilities will include creating and executing essential technical documentation to maintain compliance and enhance product quality.
Key Responsibilities:
- Troubleshoot manufacturing equipment and processes.
- Optimize critical process parameters for efficiency.
- Investigate and resolve deviations and root causes.
- Develop and execute validation protocols.
- Author technical reports to support improvements.
Must-Have Skills:
- Experience leading CQV activities in GMP environments.
- Proficiency with electronic quality and document management systems.
- Willingness to work off-shifts and weekends as needed.
Experience in the biotechnology or pharmaceutical manufacturing industry, specifically with combination products and device assembly, is highly preferred.
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