Process Engineer I, Manufacturing Sciences

4 weeks ago


Lexington, Kentucky, United States Genezen Full time
Job Summary

The Manufacturing Sciences & Technology (MSAT) group plays a critical role in successful manufacturing of clinical and commercial products. We are seeking a skilled Process Engineer I to assist the MSAT team in the transfer of technologies, process validation and cGMP manufacturing of Genezen's gene therapy products.

This individual will contribute as a core member of various cross-functional teams, and interact extensively with other departments within Genezen including Process Development, Manufacturing, Engineering, Quality, and Regulatory Affairs.

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

This role requires a strong understanding of process development, analytical development, and MSAT or GMP pharmaceutical manufacturing. The ideal candidate will have experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing and a strong background in engineering or a related scientific discipline.

The successful candidate will be able to work effectively in a fast-paced environment, prioritize tasks, and meet deadlines. Strong communication and problem-solving skills are essential for this role.

Requirements

To be considered for this role, you must have a Bachelor's or Master's degree in Engineering or a related scientific discipline. Relevant experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing is highly desirable.

Genezen offers a competitive salary and benefits package, including paid vacation days, paid sick time, and a 401(k) plan with company match. We also offer a range of employee benefits, including health insurance, dental and vision care, and a share appreciation rights program.

Genezen is an Equal Opportunity Employer and participates in EVerify. We are committed to diversity and inclusion in the workplace and welcome applications from qualified candidates of all backgrounds.



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