Lead CSV Engineer

Job Summary:

We are seeking a highly skilled CSV (Computer System Validation) Engineer to lead the validation activities for PLC-based control systems and enterprise IT systems. The ideal candidate will have extensive experience in ensuring compliance with industry standards and regulations, and possess deep expertise in system validation, quality assurance, and regulatory requirements.

Key Responsibilities:

• Lead the validation efforts for PLC-based control systems and enterprise IT systems.
• Develop, review, and approve validation documentation, including Validation Plans, IQ/OQ/PQ Protocols, and Validation Summary Reports.
• Validate Data Historian and SCADA systems to ensure reliable data capture, storage, and retrieval.
• Develop protocols for testing the accuracy and precision of historical data logging.
• Ensure Historian and SCADA systems comply with regulatory and operational standards during the validation lifecycle.
• Ensure data integrity practices are robust across all validated systems to prevent unauthorized alterations.
• Ensure compliance with FDA, EU, and other relevant regulatory standards (e.g., 21 CFR Part 11, GAMP 5).
• Collaborate with cross-functional teams, including Engineering, IT, Quality Assurance, and Regulatory Affairs, to support validation projects.
• Perform risk assessments and develop mitigation strategies for computer systems.
• Manage and coordinate validation projects, ensuring timely delivery and adherence to project timelines.
• Conduct and participate in internal and external audits as well as inspections of systems and processes to ensure ongoing compliance.
• Provide training and guidance to other team members on validation best practices.
• Stay updated with industry trends and emerging technologies to ensure continuous improvement in validation processes.

Qualifications:

• Bachelor’s degree in Engineering, Computer Science, or a related field; Master’s degree preferred.
• Minimum of 5-7 years of experience in computer system validation within the pharmaceutical, biotechnology, or related industries.
• Bachelor's degree in Engineering, Computer Science, or a related field.
• Proven experience in Computer System Validation in a regulated environment.
• Strong understanding of PLC-based control systems, SCADA and Historian, as well as enterprise IT systems.
• In-depth knowledge of regulatory requirements, including 21 CFR Part 11, GAMP 5, and other applicable standards.
• Proven track record of successful project management and leadership in validation projects.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
• Certification in validation or quality systems (e.g., ASQ, ISPE) is a plus.