Location: 
South San Francisco
Employment Type: 
Contract
Job ID: 
134211
Description: 
  • We are seeking for a senior chemical or mechanical engineer with more than 10 years of experience in the Biotech drug substance industry (large scale equipment, not filling, packaging or devices).
  • Provide engineering and project management to capital and expense projects, including direction of other technical and contract personnel
  • Participate in and/or lead engineering-related site or network improvement initiatives
  • Provide engineering expertise and support to Technology, Manufacturing, Quality, and Facility Services on a variety of production equipment (including bioreactors, buffer prep and hold tanks, centrifuge, chromatography skids and columns, filtration equipment, CIP/SIP systems, parts washers, autoclaves, and bulk freeze/thaw tanks). 
  • Provide technical and procedural guidance to junior engineers
  • Identify, analyze, and design improvements and capabilities for facility, utility, process, and equipment systems.
  • Develop and maintain engineering documentation such as PFDs, P&IDs, design drawings and specifications, technical bid evaluation, vendor print reviews, design review, and protocols (FAT, SAT, and IQ).
  • Support development and review project documentation such as schedules, budget, URS, PEP, RFQs, Contractor Bid Packages, Statements of Work, and Credit Applications.
  • Drive and manage planning and design phases including project initiation and conceptual/basic/detailed design depending on assignment.
  • Drive and manage FAT, SAT, commissioning, and installation qualification.
  • Support debug, operational and performance qualification, and handover to operations.
  • Act as Project Management on small projects.
  • Manage construction phases including contractors, construction supervision, Genentech business processes, change orders, punch-list, turnover, and closure.
  • Provide process/mechanical engineering expertise to support investigations, DMS, CAPA’s, audits, inspections, permits, and other technical requests.
  • Collaborate with Global Engineering on major facility modifications, process expansions and new construction.
  • Collaborate with peers in continuous improvement of technical infrastructure including standards, practices, specifications, procedures, and business processes.

Skills:

    • Bachelor of Science in Chemical Engineering, Mechanical Engineering or related Engineering.
    • 7+ years of GMP manufacturing experience
    • Experience with Engineering, Process Lead, Project Management, Engineering Change Control and other work processes and documentation in a GMP environment.
    • Highly self-motivated, has excellent organization and communication skills, and is able to work independently or part of a multi-disciplinary team. 
    • Must be able to function in a team environment, interacting with various functional groups, as well as in a self-managed environment
    • Ability to communicate information accurately and concisely, both verbally and in writing, to a diverse audience, in particular Manufacturing, Quality, SHE, Engineering Services, Facility Services, and Corporate Engineering
    • Ability to produce high quality and accurate work in a timely manner
    • Ability to develop into project engineering/management with associate processes and documentation.

     

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