CSV Analyst

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 specializes in supporting the validation of computerized systems within pharmaceutical and life sciences environments. This entry-level role is crucial for ensuring that these vital systems meet stringent compliance, reliability, and data integrity standards. The work directly contributes to upholding regulatory requirements across the industry.

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

• Mission: This person will ensure computerized systems in pharmaceutical and life sciences environments comply with regulatory requirements, data integrity, and reliability standards.
• Tech Stack: LIMS, ERP, MES, SCADA, SAP

What You’ll Actually Do
• Validate: Assist in the validation of various computerized systems, including LIMS, ERP, MES, and SCADA platforms.
• Document: Prepare and execute essential validation documents, covering User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Comply: Ensure that systems and processes adhere to critical regulatory requirements such as GMP, GAMP, and 21 CFR Part 11.
• Support: Provide support for validation planning, conduct risk assessments, and manage change control activities.
• Maintain: Maintain all validation documentation meticulously in line with Good Documentation Practices (GDP) standards.

The Must-Haves
• Background: Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, Engineering, or a closely related field.
• Experience: 1–2 years of experience or internship exposure within Computerized System Validation (CSV), Quality Assurance (QA), Information Technology (IT), or validation environments.
• Skills: Basic understanding of the validation lifecycle, including URS, IQ, OQ, and PQ, along with foundational knowledge of GMP and GAMP principles.
• Bonus: Familiarity with LIMS, SAP, MES, or SCADA systems; knowledge of GxP regulations, ISO standards, and ALCOA+ data integrity principles; and demonstrated strong documentation, analytical, communication skills, coupled with the ability to work independently in a remote setting.