Mfg Support Specialist 3

Prokidney

Winston, United States
On-site
Perform aseptic processing of in-house solutions
Maintain cgmp and gdp documentation standards
Execute cleaning and sanitization of gmp areas
ProKidney is seeking a Manufacturing Support Specialist III to oversee aseptic processing, GMP cleaning, and compliance with regulatory standards in a biotechnology environment. The ideal candidate will have experience in aseptic techniques and a commitment to maintaining high-quality manufacturing operations

Job Summary

  • The Manufacturing Support Specialist III plays a key leadership role in supporting manufacturing operations with a primary focus on aseptic processing and GMP cleaning.
  • This position requires expertise in performing complex aseptic processing while ensuring strict adherence to Standard Operating Procedures and regulatory guidelines.
  • As a senior contributor, the specialist will mentor junior staff, assist in deviation investigations, and drive continuous improvement of manufacturing operations.

Matching Summary

Match Score: 85

ProKidney is seeking a Manufacturing Support Specialist III to oversee aseptic processing, GMP cleaning, and compliance with regulatory standards in a biotechnology environment. The ideal candidate will have experience in aseptic techniques and a commitment to maintaining high-quality manufacturing operations.

Skills & Requirements

Must-have

  • Perform aseptic processing of in-house solutions
  • Maintain cGMP and GDP documentation standards
  • Execute cleaning and sanitization of GMP areas
  • Manage inventory and ERP system transactions
  • Participate in deviation and CAPA investigations

Nice-to-have

  • Mentor and train junior manufacturing staff
  • Lead continuous improvement initiatives
  • Collaborate with cross-functional quality teams
  • Exercise independent judgment on process issues

Key Requirements

  • 2-4 years of relevant experience in biotechnology manufacturing
  • AS/BS in Biotechnology, Biology, Chemistry, or related field
  • Demonstrated experience with aseptic techniques and GMP environments
  • Eligible to work in the United States without sponsorship

Work Rights

Must be eligible to work in the US without visa sponsorship

Tailored Resume

Cover Letter