Note: The job is a remote job and is open to candidates in USA. United Consulting Hub is seeking an entry-level CSV Engineer to support validation of computerized systems used in pharmaceutical and life sciences environments. The role ensures systems are compliant, reliable, and meet regulatory requirements.
Responsibilities
- Assist in validation of computerized systems (e.g., LIMS, ERP, SCADA, MES)
- Prepare and execute validation documents: URS, FS, DS, IQ, OQ, PQ
- Ensure compliance with Good Manufacturing Practice (GMP) and 21 CFR Part 11
- Support risk assessments and validation planning
- Maintain proper documentation per Good Documentation Practices (GDP)
- Assist in audits and inspections
- Collaborate with QA, IT, and engineering teams
- Support change control, deviation, and CAPA processes
- Ensure data integrity and system compliance
Skills
- 0-2 years of experience
- Assist in validation of computerized systems (e.g., LIMS, ERP, SCADA, MES)
- Prepare and execute validation documents: URS, FS, DS, IQ, OQ, PQ
- Ensure compliance with Good Manufacturing Practice (GMP) and 21 CFR Part 11
- Support risk assessments and validation planning
- Maintain proper documentation per Good Documentation Practices (GDP)
- Assist in audits and inspections
- Collaborate with QA, IT, and engineering teams
- Support change control, deviation, and CAPA processes
- Ensure data integrity and system compliance
- Basic knowledge of Good Manufacturing Practice and Good Automated Manufacturing Practice, with understanding of validation lifecycle (URS, IQ, OQ, PQ)
- Familiarity with computerized systems and data integrity principles
- Strong documentation, analytical, and problem-solving skills
- Good communication and basic IT knowledge
- Familiarity with systems like LIMS, SAP, MES, SCADA
- Knowledge of ISO 9001 and GxP environments
- Understanding of data integrity principles (ALCOA+)
- Internship or academic project in validation/QA/IT systems
Company Overview
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