Computer System Validation Engineer

Job Summary: The CSV Engineer / Validation Engineer will be responsible for ensuring computerized systems in a regulated pharmaceutical environment comply with GxP, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX requirements. The role involves supporting validation activities using a risk-based approach aligned with CSA principles, ensuring systems are audit-ready, and maintaining compliance throughout the system lifecycle. The position also requires hands-on involvement in documentatio

Job Summary: The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant with regulatory standards, including 21 CFR Part 11. The role requires strong expertise in GAMP 5 methodology, validation lifecycle processes, and experience with automation and control systems. This is an onsite position based in Bloomfield, Indiana. Roles & Responsibilities: Execute and manage com

Instrument Software Validation Analyst Remote - Good Validation expertise on Instrument Integrations with LIMS, CDS, etc. Overview We are seeking an experienced Instrument Software Validation Analyst to ensure that laboratory, manufacturing, and embedded software systems operate reliably, compliantly, and in accordance with regulatory requirements (GxP/FDA/EMA). The role focuses on maintaining validated systems through structured validation processes (IQ/OQ/PQ) and serves as a bridge between tec

Direct W2 contractors only! No 3rd party agencies! This is a 100 % remote role. Candidates must be located within the USA. Duration: 12 months The Hillsboro Innovative Therapies (HIT) team is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. We work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies. As a member of our Manufacturing Execution System (MES) team, you will have the