Note: The job is a remote job and is open to candidates in USA. ELIQUENT Life Sciences is seeking a Computerized Systems Validation (CSV) Engineer with SAP experience to support laboratory and IT systems in regulated life sciences environments. The role involves authoring validation deliverables to ensure compliance with FDA, EMA, and global regulatory expectations.
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
Skills
• 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
• Working knowledge of computer system validation methodologies
• Strong technical writing skills with attention to detail
• Experience consolidation 2 separate SAP systems
Company Overview
• ELIQUENT Life Sciences is a regulatory consulting firm for the life sciences industry. It was founded in undefined, and is headquartered in Washington, District of Columbia, USA, with a workforce of 501-1000 employees. Its website is https://eliquent.com.
Company H1B Sponsorship
• ELIQUENT Life Sciences has a track record of offering H1B sponsorships, with 29 in 2025, 3 in 2024. Please note that this does not guarantee sponsorship for this specific role.