CSV & SAP Consolidation Engineer

ELIQUENT Life Sciences; United States; On-site; USD 80,000 - 110,000; Full time

Job summary

A leading life sciences company is seeking a Computerized Systems Validation Engineer to support laboratory and IT systems compliance in regulated environments. This role requires experience in SAP and the ability to author validation deliverables, including protocols and reports. Candidates should have a Bachelor's degree and 2-10+ years in computerized systems validation. Strong technical writing and knowledge of FDA regulations are essential for ensuring compliance and inspection readiness.

Qualifications

• 2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries.
• Direct experience with SAP.
• Working knowledge of FDA and cGMP regulations.

Responsibilities

• Develop and maintain Design Specifications for computerized and automated systems.
• Author and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
• Generate and review validation reports.

Skills

SAP experience

Technical writing

Attention to detail

Risk-based validation

Education

Bachelor’s degree in Engineering, Computer Science, or Life Sciences

Job description

A leading life sciences company is seeking a Computerized Systems Validation Engineer to support laboratory and IT systems compliance in regulated environments. This role requires experience in SAP and the ability to author validation deliverables, including protocols and reports. Candidates should have a Bachelor's degree and 2-10+ years in computerized systems validation. Strong technical writing and knowledge of FDA regulations are essential for ensuring compliance and inspection readiness.