united consulting hubNew York, NY
CSV Analyst Entry Level
CSV Analyst Entry Level
CSV Analyst Entry Level
united consulting hubNew York, NY
today
Other Scientific and Technical Consulting ServicesPharmaceutical Preparation ManufacturingComputer Systems Design Services
Apply for this role →Job Title: CSV Analyst Entry Level
Type: Contract
Location: Hybrid
Experience: 1-2 years
Job Summary:
We are 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.
Key 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 Required 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
Preferred Skills:
- 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
Also on the board Same function, level within a rung
Level
Junior
Location
New York, NY
Occupation
Validation Engineers
Industry
Other Scientific and Technical Consulting Services
Posted
today