Process Equipment Engineer
5 days ago
Job Title: Engineer Senior
Location: Thousand Oaks, CA
Duration: 12+ Months
Description:
looking for Engineer experience in a pharma manufacturing setting with process equipment experience please**
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
• Strengths in facilitation and collaboration / networking
• Experience in developing SOPs and delivering training
• Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
• 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.)
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