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

 

NO PAID RELOCATION. NO OVERSEAS RESUMES. NO 3RD PARTIES. Applicants for employment in the US must possess work authorization which does not require sponsorship from the employer for a visa.

 

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