Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Computer Systems Validation (CSV) Specialist – Biotechnology

Job Summary:

The Computer Systems Validation (CSV) Specialist in the biotechnology industry ensures that all computerized systems related to manufacturing, laboratory, and quality control comply with regulatory standards and are validated to meet operational and quality requirements. This role focuses on supporting the validation of laboratory information management systems (LIMS), manufacturing execution systems (MES), electronic batch records (EBR), and other GxP-compliant systems essential to biotechnology operations. The CSV Specialist collaborates closely with quality assurance, IT, lab operations, and manufacturing teams to ensure system reliability, data integrity, and compliance with regulatory bodies like the FDA and EMA.

Key Responsibilities:

• Validation Planning and Strategy: Design and execute validation plans for computerized systems within biotech labs and manufacturing environments. Develop protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure systems function within defined specifications.

• System Risk Assessment: Perform risk assessments to prioritize system validation based on impact to patient safety, product quality, and regulatory compliance. Ensure validation efforts are focused on critical GxP systems.

• Validation Documentation: Prepare and maintain detailed documentation for validation activities, including validation plans, test scripts, traceability matrices, and summary reports. Ensure that documentation aligns with biotechnology industry standards and regulations.

• Testing and Verification: Oversee the execution of validation tests, verifying that systems meet functional and compliance requirements. Coordinate with laboratory and production teams to ensure smooth testing and resolve any technical issues.

• Regulatory Compliance: Ensure all computerized systems comply with biotechnology industry regulatory requirements, including FDA 21 CFR Part 11, GxP standards, and EMA guidelines. Stay current with regulatory changes and interpret how they impact validation processes.

• Change Control Management: Manage change control processes for validated systems, assessing the impact of changes on validation status and ensuring modifications do not compromise system compliance or data integrity.

• Audit Support: Support internal and external audits by providing necessary documentation and demonstrating compliance with validation and regulatory requirements. Prepare and present validation summaries as needed.

• Training and Guidance: Provide training to system owners, quality assurance, and operational teams on validation processes and regulatory requirements to ensure adherence to best practices.

• Continuous Improvement: Lead initiatives to enhance validation practices by implementing best practices and improving efficiency. Maintain an eye for process optimization, data integrity, and system reliability in line with industry advancements.

Qualifications:

• Education: Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related fields. Advanced degree preferred.

• Experience: Minimum of 3-5 years of experience in computer systems validation in the biotechnology or pharmaceutical industry.

• Technical Skills: Knowledge of validation for LIMS, MES, and EBR systems in biotech environments. Proficiency in validation lifecycle management and familiarity with software development life cycle (SDLC).

• Knowledge: Strong understanding of FDA and EMA regulatory requirements, GxP standards, and GAMP 5 guidelines for computer systems validation in biotech.

• Skills: Analytical thinking, attention to detail, and strong problem-solving skills. Proficiency in documentation and excellent written/verbal communication abilities.

Working Conditions:

This role requires working in both office settings and controlled lab/manufacturing environments. The CSV Specialist may occasionally travel to support system installations, audits, or other cross-functional requirements.

Performance Metrics:

• Timely completion of validation activities, adhering to project schedules and regulatory deadlines
• Maintenance of audit-ready documentation and successful audit outcomes
• Continuous enhancement of validation practices to support compliance and efficiency