CSV Analyst Entry Level

Job Description

CSV Analyst Entry Level | United Consulting Hub

The Tone:
This is a contract role at United Consulting Hub, located remotely. United Consulting Hub provides consulting services, focusing on the validation of computerized systems within pharmaceutical and life sciences environments. This entry-level role is crucial for ensuring that these systems are compliant, reliable, and meet all necessary regulatory requirements. The position directly contributes to maintaining high standards of data integrity and operational quality for clients.

The TL;DR
• Role: Contract / Early Career
• Type: Contract
• Location: Remote, United States

• Mission: This person supports the validation of computerized systems to ensure compliance, reliability, and regulatory adherence in pharmaceutical and life sciences environments.
• Tech Stack: LIMS, ERP, SCADA, MES, SAP

What You’ll Actually Do
• Validation Support: Assist in the validation of various computerized systems, including LIMS, ERP, SCADA, and MES, within pharmaceutical and life sciences settings.
• Documentation & Execution: Prepare and execute critical validation documents such as User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Regulatory Compliance: Ensure that computerized systems comply with Good Manufacturing Practice (GMP) and 21 CFR Part 11 regulations.
• Quality Assurance: Support risk assessments, assist with validation planning, and maintain proper documentation in accordance with Good Documentation Practices (GDP).
• Collaborative Support: Collaborate effectively with Quality Assurance, IT, and engineering teams, while also supporting processes related to change control, deviation management, and Corrective and Preventive Actions (CAPA).

The Must-Haves
• Background: Entry-level professional with a basic understanding of Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP), along with knowledge of the validation lifecycle (URS, IQ, OQ, PQ).
• Experience: 1-2 years of experience, demonstrating familiarity with computerized systems and fundamental data integrity principles.
• Skills: Strong documentation, analytical, and problem-solving skills, complemented by good communication and basic IT knowledge.
• Bonus: Familiarity with systems such as LIMS, SAP, MES, and SCADA; knowledge of ISO 9001 and GxP environments; understanding of data integrity principles (ALCOA+); or an internship/academic project in validation, QA, or IT systems.