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Validation Engineer

Winston-Salem, North Carolina, United States

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

The Associate Validation Engineer will support equipment, process, and cleaning validation activities. This role will help develop, author, review, and execute all validation protocols and reports with guidance from senior-level staff. The Validation Engineer will also help coordinate all validation activities and projects with the departmental manager. 

The Validation Engineer will be responsible for supporting the Validation/Qualification program by: 

  1. Lead validation projects to include planning, scheduling execution and reports. 
  2. Develop and Author Validation/Qualification protocols at the manufacturing facility for cleaning processes, equipment, utility, and facilities.
  3. Execute validation/qualification protocols for cleaning processes, equipment, utility, and facilities.
  4. Prepare validation/qualification summary reports for the executed protocols with support and guidance from senior level staff. 
  5. Contribute to the generation and review of required documentation (Standard Operating Procedures, protocols, change controls and change requests) to support validation activities and program. 
  6. Applies standard techniques and procedures to carry out a series of scientific and/or engineering tasks. 
  7. Provide adequate reporting and communication of projects to project manager, stakeholders and department manager. 
  8. Experience interacting with various groups at facility to develop plan/validation strategy for projects. 
  9. Experience interacting with project engineers to obtain the necessary information to fulfill validation documents. 

Requirements:

  • Associate degree in Science/Engineering or related field with 0-3 years of work experience.  
  • 1-3 years of related validation experience in a cGMP environment.
  • Basic knowledge of root cause analysis, risk assessment, and investigation tools/techniques in cGMP.
  • Minimum of 3 years of prior experience developing, authoring, and executing validation protocols in a manufacturing environment. 
  • Knowledge and understanding of the validation lifecycle.
  • Strong Mechanical aptitude
  • Strong technical writing skills. 
  • Experience with equipment qualification methodologies. 
  • Ability to read/interpret P&ID drawings

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment. 

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