CSV Engineer (Computerized System Validation)

Job Summary

As a CSV Engineer, you will be responsible for the Computerized Systems Validation (CSV) scope and collaboration with the Automation team. Your expertise in CSV, along with experience in large-scale projects and PLC/DeltaV systems, will contribute to the successful execution of projects in biopharmaceutical manufacturing facilities

Responsibilities

• Lead the Computerized Systems Validation (CSV) process to ensure compliance with industry regulations and standards.
• Collaborate with the Automation team to integrate CSV activities within project timelines.
• Develop and execute validation protocols, test documentation, and CSV project deliverables.
• Liaise with departments, project managers, and vendors to coordinate CSV activities.
• Provide technical support to the Automation group during field execution and report writing.
• Generate and manage project change controls as required.
• Support Design Qualification efforts and participate in risk assessments.
• Adapt to changing project requirements and timelines.
• Maintain accurate documentation and records related to CSV activities.

• Bachelor's degree in a relevant field (Engineering, Computer Science, etc.) is preferred.
• Minimum of 4/5 years of experience in CSV.
• Strong knowledge and experience with PLC and DeltaV systems.
• Experience working on large-scale projects.
• Preferred familiarity with design and construction projects in biopharmaceutical manufacturing facilities.
• Excellent communication and interpersonal skills.
• Strong problem-solving and analytical abilities.
• Ability to work effectively in a team environment.