Manager, Process Development and Automation - Pre-Analytical
Redwood - 301 Galveston, United States
USD 140K-238K Mid-level Full Time
Tasks
- Apply robust design principles to laboratory solutions
- Coach mentor and train team members
- Collaborate on root cause analysis for production failures
- Conduct risk assessments and validation planning
- Coordinate training methodology and documentation
- Drive continuous improvement projects
- Ensure compliance with quality management system policies
- Improve technical documentation and laboratory processes
- Lead issue escalation for instrumentation problems
- Lead process and product development in a regulated environment
- Maintain quality of mechanical work and documentation
- Manage support request routing and resolution
- Oversee assay workflows
- Provide technical guidance to PDA engineers and scientists
Perks/Benefits
- Dental insurance
- Health insurance
- Paid parental leave
- Paid time off
- Retirement savings plan
- Vision insurance
- Wellness support
Skills/Tech-stack
21 CFR | 21 CFR Part 210 | 21 CFR Part 211 | 21 CFR part 820 | CAP | CFR Part 820 | CGMP | CLIA | Cause analysis | Design for Six Sigma | Design of Experiments | FMEA | ISO 13485 | Information System | JMP | Laboratory Information System | Laboratory automation | Management System | Microsoft Excel | Microsoft Office | Microsoft PowerPoint | Microsoft Word | Part 210 | Part 211 | Part 820 | Process validation | Quality Management System | Quality management | Regulatory Compliance | Risk Assessment | Robust Design | Root Cause Analysis | Root cause | Six Sigma | SolidWorks | System Requirements | Traceability matrix | UAT | User Requirements
Education
Associate Degree | Bachelor of Engineering | Bachelor of Science
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