Description: Our client is currently seeking an Engineer Senior
Basic Qualifications
Doctorate degree OR Master's degree & 3 years of engineering and/or manufacturing experience OR Bachelor's degree & 5 years of engineering and/or manufacturing experience OR Associate's degree & 10 years of engineering and/or manufacturing experience OR High school diploma / GED & 12 years of engineering and/or manufacturing experience
Preferred Qualifications / Skills / Experience
• Bachelor's degree in engineering or another science-related field
• 7+ years of relevant work experience with 5+ years' experience in operations/manufacturing environment
• 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
• Demonstrated strong communication and technical writing skills
• Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
Contact: skumar09@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com