Sr. Engineer/ Manager, Process Development

Department
Process Development

Location
San Diego

Summary Description
The Sr. Engineer/ Manager 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, Process Development and Production.

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

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 PhD 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.)
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