Senior Engineer

Senior Engineer

 
Job ID: Job-2137       
Job Title:      Senior Engineer
location:       Berkeley, CA   
Jobtype:        Permanent      
               
Description:    Qualifications: 
• Bachelor’s Degree in the Chemical, Biochemical or Mechanical Engineering field and Six to eight or more (6-8+) years of experience OR 
• Master’s Degree in the Engineering field and up to four or more (0-4+) years of experience OR 
• PhD in the Engineering field and up to two (0-2) years of experience 
• 5+ years of experience with Engineering in GMP regulated environment direct experience in qualification of process systems 
• Understanding of biotechnology processes 
• Knowledge of mechanical systems and clean utilities, presentation, and interpersonal skills 
• Experience in project scheduling, budgeting and cost control 
• Knowledge of process control systems (PCS) 
• Holistic understanding of Engineering systems. 

Preferred Qualifications 
• Supervisory and managerial experience 
• Familiarity with ASTM-E2500 & GAMP 
• Statistics (SPC) experience 
• Knowledge of ICH/ISO/ISPE C&Q Baseline Guide/PDA Technical Reports, etc. 
• Knowledge of CFR requirements/ EU/ JP/ MHRA/ Canada and how to apply these requirements 
• Knowledge of Risk management and Risk Analysis Tools, e.g. ICH 8, 9, 10 
• Knowledge of best practices in the industry for development of engineering standards for pharma/biotech design/ construction/operation/maintenance. 

Responsibilities 
• Collaborate with project stakeholders to determine qualification requirements adhering to applicable industry regulations and guidelines 
• Coordinate, manage and perform the C&Q project activities 
• Generate, review and execute C&Q documentation and protocols 
• Communicate progress to core team members on project C&Q objectives and timelines 
• Maintain clear, detailed records of qualification, and change control activities. 

Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume. I will only respond to resumes that demonstrate a fit for the role. 

PAID RELOCATION. ONLY THOSE AUTHORIZED TO WORK IN THE US. VISA TRANSFERS ARE NOT AVAILABLE AT THIS TIME. NO 3RD PARTIES. NO OVERSEAS RESUMES, PLEASE. 

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