CSV/SAP Consolidation Consultant

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

We are seeking a Computerized Systems Validation (CSV) Engineer with SAP experience to join our team. This role will focus on supporting laboratory and IT systems in regulated life sciences environments. The CSV Engineer will author validation deliverables—including protocols, reports, and SOPs—ensuring compliance with FDA, EMA, and global regulatory expectations.

***Candidates MUST have experience consolidation 2 separate SAP systems

Key Responsibilities

• Develop and maintain Design Specifications (DS) for computerized and automated systems.
• Author and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
• Generate and review validation reports and Validation Summary Reports (VSRs).
• Author and maintain Standard Operating Procedures (SOPs) for validated systems and equipment.
• Support implementation of CSV activities for IT and manufacturing automation systems in GMP environments.
• Apply risk-based validation approaches in alignment with industry standards and regulatory guidance.
• Partner with Quality, Engineering, and IT teams to align validation deliverables with compliance and business needs.
• Contribute to inspection readiness by ensuring validation documentation meets regulatory expectations.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
• 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 and documentation practices
  • Computer system validation methodologies
• Strong technical writing skills with attention to detail.