CSV Engineer

Job Description

CSV Analyst Entry Level | United Consulting Hub

The Tone:
This is a contract role at United Consulting Hub, located in NJ. United Consulting Hub plays a critical role in ensuring the integrity and compliance of computerized systems within highly regulated pharmaceutical and life sciences environments. This entry-level position is vital for contributing to the validation processes that ensure these essential systems not only function reliably but also meet rigorous regulatory requirements. You will gain foundational experience supporting key initiatives that uphold data integrity and system compliance across a variety of complex industry applications.

The TL;DR
• Role: Contract / Early Career
• Type: Contract
• Location: In-person, NJ

• Mission: Support the validation of computerized systems to ensure compliance, reliability, and regulatory adherence in pharmaceutical and life sciences settings.
• Tech Stack: LIMS, ERP, SCADA, MES, SAP, ISO 9001, GxP

What You’ll Actually Do
• Validate: Assist in the validation of various computerized systems, including LIMS, ERP, SCADA, and MES, used in critical pharmaceutical and life sciences environments.
• Document: Prepare and execute essential validation documents such as User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).
• Comply: Ensure all system validation activities adhere to Good Manufacturing Practice (GMP) and 21 CFR Part 11 regulatory requirements, maintaining a compliant operational status.
• Support: Provide support for risk assessments, comprehensive validation planning, and maintaining proper documentation in strict accordance with Good Documentation Practices (GDP).
• Collaborate: Work closely with Quality Assurance (QA), IT, and engineering teams to support change control, deviation, and Corrective and Preventive Action (CAPA) processes, ensuring system integrity.

The Must-Haves
• Background: This entry-level position is ideal for an individual with 0-2 years of professional experience, who possesses a foundational understanding of Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP).
• Experience: Candidates should demonstrate an understanding of the full validation lifecycle, encompassing User Requirement Specifications (URS) through Installation, Operational, and Performance Qualifications (IQ, OQ, PQ). Familiarity with the operational principles of computerized systems and core data integrity principles is also essential.
• Skills: You will need strong documentation skills to prepare and maintain meticulous records, sharp analytical and problem-solving abilities to address system challenges, good communication skills for team collaboration, and basic IT knowledge to navigate technical environments effectively.
• Bonus: Preferred qualifications include familiarity with specific systems such as LIMS, SAP, MES, or SCADA, knowledge of ISO 9001 and GxP environments, a solid understanding of ALCOA+ data integrity principles, or relevant internship or academic project experience within validation, Quality Assurance, or IT systems.