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Process Engineer I, Manufacturing Sciences

1 month ago

Lexington, Kentucky, United States Genezen Full time

Genezen is a cutting-edge biotechnology company dedicated to advancing gene therapy and delivering innovative treatments to patients. We are seeking a highly skilled Process Engineer I to join our Manufacturing Sciences team.

The successful candidate will assist in the transfer of technologies, process validation, and cGMP manufacturing of Genezen's gene therapy products. This role requires strong communication skills, attention to detail, and the ability to work collaboratively with cross-functional teams.

Key responsibilities include:

  • Assisting technology transfer to GMP manufacturing facilities by reviewing master batch records and providing on-floor support for transfer operations
  • Verifying technical data in support of reports, impact assessments, and memos
  • Assisting manufacturing technical support, including process trouble-shooting, root cause analysis, and investigation of process and/or quality discrepancies and deviations during GMP productions, change controls, and CAPAs
  • Cross-functionally collaborating with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation, and Supply Chain as needed
  • Supporting planning and execution of process/product life cycle management, including continuous process improvements to improve process robustness/capacity/productivity and increase the level of safety and/or compliance

Genezen offers a dynamic and rewarding work environment, with opportunities for professional growth and development. We are committed to delivering quality results and upholding ethical principles.

Requirements include:

  • Bachelor's Degree in Engineering or a related scientific discipline
  • Master's Degree in Engineering or a related scientific discipline (desired)
  • BS (0-3) or MS (0-1) with relevant experience or degree in gene therapy or other biotechnology field
  • Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal
  • Ability to present to and interact with others to achieve cross-functional goals
  • Ability to handle pressure and address multiple topics in parallel to meet with timelines
  • Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner

Genezen is an Equal Opportunity Employer and participates in EVerify. We are interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.