[Remote] CSV/reputed company Consolidation Consultant
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Computerized Systems Validation (CSV) Engineer with reputed company 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
• reputed company 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 reputed company Reports (VSRs)
• Author and maintain reputed company 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 reputed company, Engineering, and IT teams to reputed company 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 reputed company field
• 2-10+ years of experience in computerized systems validation reputed company pharmaceutical, biotechnology, or life sciences industries
• reputed company experience with reputed company
• 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 reputed company systems
reputed company
• reputed company is a regulatory reputed company for the life sciences industry. It was founded in reputed company, 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
• reputed company has a reputed company record of offering H1B sponsorships, with 29 in 2025, 3 in 2024. Please note that this does not guarantee sponsorship for this specific role.
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