Process Development Engineer

Hologic-posted 3 months ago
$78,300 - $122,400/Yr
Full-time • Mid Level
San Diego, CA
5,001-10,000 employees
Computer and Electronic Product Manufacturing
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

This Process Development Engineer role in the Operations - Process Transfer group requires technical expertise in developing and troubleshooting manufacturing process in NPD and Sustaining, for oligonucleotides, Master Cell Banks, plasmids, transcripts, sub-assemblies, protein, final formulations and/or lyophilized finish product. In this role, you will lead the development, validation, transfer and implementation of new manufacturing processes; plan and execute experiments to develop process parameters and/or bring resolution to investigations resulting from non-conformances; and participate in new product development, scale-up and optimization projects and core teams. This is a fully onsite role based out of San Diego, CA.

  • Serve as subject matter expert (SME) in oligonucleotides, Master Cell Banks, plasmids, transcripts, sub-assemblies, protein, final formulations and/or lyophilized finish product GMP manufacturing.
  • Troubleshoot complex manufacturing process problems.
  • Define, monitor and analyze process parameters and data (KPIs and CQAs).
  • Ensure availability of equipment/instrumentation for GMP use.
  • Research, evaluate and purchase new raw material, instruments and equipment.
  • Utilize root cause analysis to resolve non-conformances.
  • Independently generate experiments to obtain root cause.
  • Independently generate notebook studies, development reports, technical reports, development documents and manufacturing documents.
  • Plan and execute CAPAs that result from non-conformance investigations.
  • Develop, improve, validate and implement GMP manufacturing processes.
  • Train personnel in new manufacturing processes.
  • Participate in the transfer of GMP processes to and from other manufacturing sites.
  • Serve as SME oversight for outsourcing manufacturing.
  • Represent department as Core Team or Extended Core Team member as part of New Product Introductions.
  • Minimum of a Bachelor's Degree, preferably in Chemical Engineering, Biomedical Engineering, or relevant fields.
  • Minimum of 5 years of diagnostic product/process development/transfer experience in a regulated environment (Medical Device or Pharmaceutical).
  • Certification in CQE / Six Sigma Green Belt highly preferred.
  • Working knowledge of QSR/QMS application.
  • Comprehensive training when you join as well as continued development and training throughout your career.
Track Jobs with Teal

Job Search Resources

•
AI Resume Builder
•
Process Development Engineer Resume Examples
•
Process Development Engineer Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service