Computer System Validation Csv Engineer Ebr

Job Title: Computer System Validation (CSV) Engineer EBR & Automation
Company: Intellectt Inc.
Location: Swiftwater, PA
Employment Type: W2 Contract
Pay Rate: $40-45/hour
Work Arrangement: Onsite

Job Summary
We are seeking a CSV Engineer to support the validation of Electronic Batch Record (EBR) systems and integrations with manufacturing automation systems in a GMP-regulated environment. The candidate will develop validation documentation, execute testing, and collaborate with Manufacturing, Automation, IT, and Quality teams.

Key Responsibilities

• Validate EBR systems and interfaces with manufacturing automation systems.
• Develop and review User Requirements Specifications (URS), Functional Specifications (FS), and validation plans.
• Prepare and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Verify system functionality, interface data flow, and requirements traceability.
• Document test results, investigate discrepancies, and coordinate corrective actions.
• Support risk assessments, change controls, and validation summary reports.
• Ensure validation activities follow GMP, data integrity, and applicable electronic records requirements.

Required Skills and Experience

• Hands-on CSV experience in pharmaceutical or biotechnology manufacturing.
• Experience validating EBR systems and automation system integrations.
• Strong experience authoring URS, functional specifications, and IQ/OQ/PQ documentation.
• Understanding of GMP, GAMP 5, 21 CFR Part 11, and data integrity principles.
• Ability to work independently and coordinate with technical and quality stakeholders.
• Availability to work onsite in Swiftwater, PA.

Key Skills: Computer System Validation (CSV), Electronic Batch Records (EBR), Manufacturing Automation Systems, GMP, GAMP 5, FDA 21 CFR Part 11, Data Integrity, URS, Functional Specifications (FS), IQ/OQ/PQ, Validation Protocols.

Recruiter Contact:

Rudra Prasad Kunnath
Email:
Phone:

Benefits: Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.

Equal Employment Opportunity: