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Process Engineer III
Ref No.: 20-02340
Location: Vacaville, California
Considered the founder of the industry, our client has been delivering on the promise of biotechnology for over 40 years. Our client is considered the leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.
Process Engineer Project Manager
1000 New Horizons Way, VACAVILLE
*This role will start off remote until shelter in place is lifted

Job Description
  • Facilities and Engineering seeks a competent and energetic Engineer/Senior Engineer, who will report to the Head of Engineering within the Facilities and Engineering Department and provide engineering leadership and support to the manufacturing operations and GMP equipment in Vacaville, including the following responsibilities:
  • Reporting to the Director of Engineering within the Facilities and Engineering Department and supported by other senior engineers to provide engineering support to the operations in Vacaville. Engineering supports the Technical transfer and GMP Process areas and may include the following responsibilities:
  • 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, *** 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.
  • 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.
  • Bachelor of Science in Chemical Engineering, Mechanical Engineering or related Engineering.