Engineering Manager/Associate Director, Process Development - San Diego, CA | Biospace
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Engineering Manager/Associate Director, Process Development

PaxVax, Inc.

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Location:
San Diego, CA
Posted Date:
7/16/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Engineering, Process, Process Development, Process Engineer,

Job Description

The Engineering Manager/Associate Director, Process Development is responsible for leading the engineering team for cGMP facilty and process equipment design, scale-up, specifications, installations, commissioning, and technical support. This position reports directly to the Director of Process Development.

Responsibilities:
•   Engineering oversight of cGMP facilities, utilities, and process equipment, including design, scale-up, specifications, installations, commissioning, and technical support
•   Manage contractors and vendors related to new process equipment, utilities, and facilities
•   Perform cost analysis to support new programs, scale-up proposals, and upgrades to existing systems
•   Develop best practices, routines and innovative solutions to improve process and quality of output.
•   Perform risk assessment, incident investigation and corrective actions
•   Provide process documentation and operating instructions.
•   Provide technical support to process development and clinical production teams
•   Vision to guide a team in engineering requirements when developing a new production process.
•   Develop engineering lab for custom fabrication of process equipment.
•   Develop process for creation, part numbering and control of custom CAD drawings to define custom process equipment to be used for GMP manufacturing.
•   Manage engineering project budgets and timelines

Requirements

Technical Skills and Knowledge:
•   Knowledge in design cGMP manufacturing facility
•   Knowledge in FDA and ISO guidelines.
•   Knowledge in computer system validation
•   Knowledge in AutoCAD
•   Knowledge in FMEA, risk analysis, process characterization
•   ISPE certification is preferred.
•   Bioprocess experience (bioreactor, chromatography) is preferred.
•   Analytical thinker with interpersonal skills.
•   Attention to details.
•   Good technical writing skills
•   Good communication skills
Qualification Requirements:
•   Minimum of 10 years' relevant industry experience
•   B.E, M.E. or Ph.D. in engineering
•   Proven work experience in facility and process engineering
•   Proven collaboration skills, learning agility, conceptual and strategic thinking, passion for results, and ability to navigate ambiguity
Travel:
•   Occasional (equipment selection, factor acceptance testing, conferences, etc.)