Computer System Validation Engineer

Position Summary

The Computer System Validation (CSV) Engineer II will ensure compliance of computerized systems within a pharmaceutical manufacturing environment. This role focuses on the development, execution, and closure of Installation, Operational, and Qualification (IOQ) protocols for critical systems, including SCADA and Manufacturing Execution Systems (MES). The engineer will work in a cleanroom environment alongside manufacturing equipment to support system qualification activities in accordance with regulatory requirements (FDA, EU GMP, GAMP 5).

Responsibilities

• Develop and author IOQ protocols for computerized systems, ensuring alignment with user requirements and regulatory standards.
• Execute IOQ protocols in a cleanroom environment, coordinating with cross-functional teams (Engineering, QA, Manufacturing).
• Perform data collection, deviation management, and ensure timely resolution of discrepancies during qualification activities.
• Generate and finalize IOQ reports, ensuring complete documentation and compliance with internal SOPs and industry guidelines.
• Support the qualification of iFIX SCADA system and related MES components for manufacturing operations.
• Collaborate with IT and Automation teams to ensure system configurations meet validation requirements.
• Maintain validation documentation in compliance with FDA 21 CFR Part 11 and other applicable regulations.
• Participate in risk assessments and impact analyses for system changes.

Qualifications & Requirements

• Education: Bachelor's degree in Engineering, Computer Science, or related field.
• Experience:
• 2–4 years of experience in Computer System Validation within a pharmaceutical or regulated industry.
• Hands-on experience with Manufacturing Execution Systems (MES) and iFIX SCADA system qualification.
• Strong understanding of GAMP 5, FDA, and EU GMP guidelines.
• Familiarity with cleanroom operations and manufacturing equipment integration.
• Excellent technical writing and documentation skills.
• Ability to work independently and manage multiple validation projects simultaneously.

Preferred Qualifications

• Knowledge of automation systems and PLCs.
• Experience with electronic batch records and data integrity principles.
• Strong problem-solving and analytical skills.

Salary Range

• $95,000 - 110,000
• The actual salary offered is dependent on various factors including, but not limited to, location, the candidate's combination of job-related knowledge, qualifications, skills, education, training, and experience