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Full-Time

Sr. Validation Engineer

Confirmed live in the last 24 hours

ProKidney

ProKidney

51-200 employees

Develops cell therapy for chronic kidney disease

Biotechnology
Healthcare

Senior

Winston-Salem, NC, USA

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

ProKidney focuses on treating Chronic Kidney Disease (CKD) through a novel cell therapy called rilparencel. This therapy aims to preserve kidney function in patients with advanced CKD, potentially delaying or eliminating the need for dialysis, which many patients currently rely on. ProKidney is in the late stages of clinical trials, and early results indicate that rilparencel may effectively maintain kidney function. Unlike other treatments, ProKidney specifically targets CKD, a condition affecting over 35 million adults in the U.S., and aims to fill a significant gap in available therapies. The company's goal is to provide a groundbreaking treatment that improves the quality of life for CKD patients and reduces their reliance on dialysis.

Company Stage

IPO

Total Funding

$559.3M

Headquarters

Winston-Salem, North Carolina

Founded

N/A

Growth & Insights
Headcount

6 month growth

11%

1 year growth

47%

2 year growth

82%
Simplify Jobs

Simplify's Take

What believers are saying

  • Successful $140 million public and direct offering boosts financial stability and supports ongoing R&D efforts.
  • The potential approval and commercialization of rilparencel could revolutionize CKD treatment and significantly improve patient quality of life.
  • Expansion plans, including a new facility in Greensboro, promise job creation and economic growth.

What critics are saying

  • The biotech sector's inherent volatility, as evidenced by ProKidney's significant stock price fluctuations, could impact financial stability.
  • Dependence on the successful approval and commercialization of rilparencel means any regulatory setbacks could severely affect the company's prospects.

What makes ProKidney unique

  • ProKidney is pioneering a novel cell therapy, rilparencel, specifically targeting CKD, unlike many competitors who focus on broader therapeutic areas.
  • Their focus on delaying or eliminating the need for dialysis offers a unique value proposition in the CKD treatment landscape.
  • ProKidney's late-stage clinical trials and promising early data position it as a frontrunner in CKD cell therapy innovation.