Full-Time
Associate Validation Engineer
Confirmed live in the last 24 hours
ProKidney
51-200 employees
Develops cell therapy for chronic kidney disease
Entry
Winston-Salem, NC, USA
- 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.
- Lead validation projects to include planning, scheduling execution and reports.
- Develop and Author Validation/Qualification protocols at the manufacturing facility for cleaning processes, equipment, utility, and facilities.
- Execute validation/qualification protocols for cleaning processes, equipment, utility, and facilities.
- Prepare validation/qualification summary reports for the executed protocols with support and guidance from senior level staff.
- Contribute to the generation and review of required documentation (Standard Operating Procedures, protocols, change controls and change requests) to support validation activities and program.
- Applies standard techniques and procedures to carry out a series of scientific and/or engineering tasks.
- Provide adequate reporting and communication of projects to project manager, stakeholders and department manager.
- Experience interacting with various groups at facility to develop plan/validation strategy for projects.
- Experience interacting with project engineers 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
6 month growth
↑ 14%1 year growth
↑ 50%2 year growth
↑ 87%
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.
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