Manufacturing Engineer II/III
Lab Support - San Diego, CA

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Our client, a leading developer in the biologics space, is seeking an experienced Manufacturing Engineer to join their team on a DIRECT HIRE basis.

The incumbent will be responsible for supporting manufacturing operations by working as an operator in all aspects of plasmid DNA manufacturing, including fermentation, centrifugation, lysis, and chromatographic processes and by applying engineering knowledge to troubleshoot problems and improve production capabilities. The Manufacturing Engineer will work with Process Development Engineers, Facility Engineers, and other associated groups to implement and validate new processes and procedures, troubleshoot equipment, and optimize overall system performance. He or she may be involved in the design, installation, and validation of new cGMP equipment. In addition, the Manufacturing Engineer will assist the Facilities department during periodic plant shutdowns to coordinate equipment maintenance and instrument calibration. Some after-hours work and participation in a rotating after-hours process control function may be required.

Job Knowledge and Experience

The ideal candidate will possess:
  • Experience working with pilot- or commercial-scale processing equipment such as stirred-tank bioreactors, continuous-flow centrifuges, ultrafiltration skids, process tanks, and automated CIP/SIP systems
  • Experience working in a cGMP environment, including in-depth knowledge of current Good Manufacturing Practices, validation, process engineering, quality system regulations, and ISO standards
  • The ability to communicate clearly and precisely, both orally and in writing
  • Confidence, initiative, strong interpersonal and collaborative skills, and good personal organization skills
  • Ability to independently identify problems and effectively offer solutions to problems
  • Ability to work on multiple tasks simultaneously and meet project deadlines
  • Experience working on cross-functional teams and a commitment to working in a fast-paced environment

A Bachelors or Masters Degree in Chemical or Biochemical Engineering or related discipline with a minimum of 3 to 8 years’ experience in a manufacturing pharmaceutical/biotechnology environment. *Candidates experience will determine their job title

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