Biotech CSV Engineer: Validate GxP Systems & Compliance

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

Benefits offered by this job

Medical insurance coverage

Dental and vision coverage

401k match plan

Lifestyle spending account

PTO: 160 hours of paid time off

Job summary

A leading biopharmaceutical company in Cleveland, Ohio, seeks a Computer System Validation Engineer to ensure compliance for GxP-regulated computerized systems. This role involves developing validation deliverables and collaborating with cross-functional teams to maintain standard operating procedures that meet FDA regulations. The ideal candidate will have a Bachelor's degree and 3-5+ years of experience in the biotech or pharmaceutical industry. Competitive pay and benefits are offered, including medical, dental, and PTO policies.

Qualifications

• 3-5+ years of experience in CSV within the biotechnology or pharmaceutical industry.
• Familiarity with cloud-based systems and their validation challenges.
• Experience validating GxP systems with software components.

Responsibilities

• Develop and execute validation deliverables for new and existing GxP systems.
• Lead CSV efforts for systems supporting biotech processes.
• Ensure documentation practices meet internal SOPs.

Skills

Strong working knowledge of FDA regulations

Attention to detail

Excellent written and verbal communication skills

Highly organized

Ability to manage multiple priorities

Experience with GxP systems

Education

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

Tools

LIMS

QMS

ERP

Job description

A leading biopharmaceutical company in Cleveland, Ohio, seeks a Computer System Validation Engineer to ensure compliance for GxP-regulated computerized systems. This role involves developing validation deliverables and collaborating with cross-functional teams to maintain standard operating procedures that meet FDA regulations. The ideal candidate will have a Bachelor's degree and 3-5+ years of experience in the biotech or pharmaceutical industry. Competitive pay and benefits are offered, including medical, dental, and PTO policies.