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Sr. 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 Sr. Validation Engineer will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA’s guide to Computer Software Assurance. Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.

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

  1. Lead system validation projects to include planning, scheduling, execution and reports.
  2. Track and resolve deviations/exceptions during qualification activities.
  3. Work with company management to implement changes and upgrades to computer systems
  4. Work with vendors on purchasing and planning for new lab equipment/software upgrades, review vendor protocols/design specifications
  5. Communicate System Validation approaches and requirements during audits.
  6. Perform gap assessments for further enhancements, validation, or system upgrades/fixes based on risk based.
  7. Contribute to the generation and review of required documentation (Standard Operating Procedures, protocols, change controls and change requests) to support validation activities and program.
  8. Establish a Data Integrity program mostly for the QC labs and Manufacturing systems.
  9. Provide adequate reporting and communication of projects to project manager, stakeholders and department manager.
  10. Experience developing plans/validation strategies for projects.
  11. Experience interacting with system owners and IT to obtain the necessary information to fulfill validation documents.

Minimum Requirements

  • Bachelor's Degree in Computer Science, Science/Engineering, or a related field with 5+ years of work experience.
  • 10+ years of system validation experience in a cGMP environment. (preferable pharmaceutical)
  • Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.
  • Experience in writing computer system test scripts, validation protocols and summary reports
  • Knowledge of Regulatory Requirements, 21CFR11, Data Integrity Guidance, GAMP and industry best practices for validation to complete tasks
  • Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc
  • Detail orientated and ability to work in a fast-paced environment with the ability to handle multitude of projects with overlapping schedules.
  • Knowledge and understanding of validation lifecycle.
  • Proficient in analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution
  • Capable of managing multiple sub-projects, duties and tasks
  • Able to work in a startup high pace company

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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