Principal Engineer, Commissioning and Qualification Berkeley, CA
Job ID: Job-2651
Job Title: Principal Engineer, Commissioning and Qualification
location: Berkeley, CA
Jobtype: Permanent
Rate: $80K - $115K +bonus
Primary Skills:
Description:
Qualifications:
• Bachelor’s Degree in the Chemical, Biochemical or Mechanical Engineering field and eight or more (8+) years of experience OR
• Master’s Degree in the Engineering field and six or more (6+) years of experience OR
• PhD in the Engineering field and four or more (4+) years of experience AND
• 8+ years of experience with Engineering in GMP regulated environment direct experience in qualification of process systems
• Supervisory and managerial experience
• Ability to lead, develop, and maintain good working relationships with employees from diverse disciplines
• Ability to provide practical, specific guidance to colleagues regarding the knowledge of appropriate compendia/industry guidance and regulatory requirements
• Ability to effectively develop and communicate requirements with rationale to all levels of the organization
• Understanding of biotechnology processes and knowledge of mechanical systems and clean utilities
• Strong written and verbal skills
• Experience in project scheduling, budgeting and cost control.
Plusses
• Familiarity with ASTM-E2500 & GAMP
• 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.
Email resume in Word to JeffAltman@TheBigGameHunter.us. Please include the job code for the position with your resume. NOTE: WE WILL ONLY RESPOND IF YOUR RESUME APPEARS TO FIT A ROLE
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