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Senior Engineer
2 months ago
Senior Engineer (Onsite Job)
Location: Thousand Oaks, CA
Terms: Contract W2
Duration : 12 Months Contract (Can Be Extended For Long)
Description:
FULLY ONSITE AT USTO
Standard business hours
Need hands on Engineer in GMP environment
Bachelors should be in any engineering environment
Troubleshooting
Like to see any Chemical Engineer/ Maintenance Engineer/ Process Engineer/ Manufacturing Engineer/ Automation Engineer/ Formulation Engineer/ Process Development Engineer or Any
NOTES FROM HIRING MANAGER:
Looking for hands on *STRONG* engineer experience with proper training/ background in technical side/ mathematics.
The job seeker needs to be practical with troubleshooting and be able to hold a technical conversation.
Transferrable Industry backgrounds: Drug substance/ pharma / chemical/ oil refinery/ mechanical.
Preferred Qualifications (Nice To Have)
• Bachelor's degree in engineering or another science-related field
• Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
• Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
• Understanding and awareness of industry/regulatory trends for verification/validation
• Experience with combination product / medical device quality systems verification
• Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
• Strong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.
o Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
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