CSV Engineer - Onsite Biotech with Remote Day

Abeona Therapeutics; Cleveland (OH); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental, and Vision insurance

401(k) with 4% company match

Health Savings Account

Flexible Spending Account

160 hours of Paid Time Off

Snack/Drink Rooms

Lifestyle Spending Account

Job summary

Abeona Therapeutics in Cleveland, Ohio is looking for a Computer Systems Validation Engineer to ensure health care solutions meet quality standards. You will validate GxP-regulated computerized systems and work with cross-functional teams. Required: Bachelor’s degree and 3-5+ years experience in CSV, knowledge of FDA regulations, and excellent communication skills. This is a full-time role with competitive salary ($80,000-$100,000) and benefits such as medical insurance and 160 hours of PTO.

Qualifications

• 3-5+ years of experience in CSV within the biotechnology or pharmaceutical industry.
• Strong working knowledge of GAMP 5 and data integrity principles.
• Experience validating GxP systems such as LIMS, QMS, ERP, or laboratory equipment.

Responsibilities

• Ensure that computerized systems are validated and maintained in compliance with FDA and EMA.
• Collaborate closely with cross-functional teams on compliance initiatives.
• Conduct risk assessments and ensure data integrity.

Skills

GxP computer system validation

FDA regulations

Excellent written and verbal communication

Project management

Education

Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field

Tools

LIMS

QMS

SaaS platforms

Job description

Abeona Therapeutics in Cleveland, Ohio is looking for a Computer Systems Validation Engineer to ensure health care solutions meet quality standards. You will validate GxP-regulated computerized systems and work with cross-functional teams. Required: Bachelor’s degree and 3-5+ years experience in CSV, knowledge of FDA regulations, and excellent communication skills. This is a full-time role with competitive salary ($80,000-$100,000) and benefits such as medical insurance and 160 hours of PTO.