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:

Senior Validation Specialist – Biotechnology

Job Summary:

The Senior Validation Specialist in the biotechnology industry is responsible for overseeing and executing validation activities for critical GxP-regulated systems, processes, and equipment used in manufacturing, laboratory, and quality control. This role involves leading validation projects, developing validation strategies, and ensuring compliance with regulatory standards such as FDA, EMA, and other global health authorities. The Senior Validation Specialist collaborates across departments to implement best practices, troubleshoot complex issues, and support continuous improvement efforts in validation processes.

Key Responsibilities:

• Validation Strategy and Execution: Lead validation projects, including developing, executing, and reviewing protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases. Define validation strategies to ensure compliance and efficiency.

• Process and Equipment Validation: Oversee validation of biotech processes, equipment, utilities, and computerized systems, including bioreactors, chromatography systems, autoclaves, and clean rooms, ensuring that all critical equipment meets regulatory and operational standards.

• Risk-Based Validation Approach: Conduct risk assessments to prioritize validation activities based on potential impact to product quality, patient safety, and regulatory compliance. Use a science- and risk-based approach to validate systems that are critical to GxP processes.

• Document Management: Develop, review, and maintain validation documentation, including validation plans, protocols, reports, and traceability matrices. Ensure all documentation is audit-ready and in line with regulatory expectations.

• Regulatory Compliance and Industry Standards: Ensure compliance with regulatory guidelines, including FDA 21 CFR Part 11, GAMP 5, and ICH Q9, by staying up-to-date with regulatory trends and industry best practices. Interpret regulatory requirements and provide guidance to project teams.

• Cross-Functional Collaboration: Work closely with quality assurance, manufacturing, IT, and engineering teams to align on validation requirements and support the successful implementation of new equipment, systems, and processes.

• Deviation and Change Control Management: Manage deviations, change controls, and non-conformances related to validation activities. Ensure all changes are thoroughly evaluated for impact on validation status and regulatory compliance.

• Audit Preparation and Support: Serve as a subject matter expert during internal and external audits. Provide detailed explanations and documentation to auditors, and lead efforts to address validation-related findings.

• Training and Mentorship: Train and mentor junior validation team members and system owners on validation processes and regulatory expectations. Provide guidance on best practices and promote continuous improvement.

• Continuous Improvement Initiatives: Drive improvement projects to streamline validation processes, increase efficiency, and reduce validation cycle times while ensuring compliance and quality standards.

Qualifications:

• Education: Bachelor’s degree in Life Sciences, Engineering, or related field. Advanced degree (Master’s or PhD) in Biotechnology, Biochemistry, or related field preferred.

• Experience: Minimum of 5-7 years of experience in validation within the biotechnology or pharmaceutical industry, including hands-on experience with equipment, process, and computer system validation.

• Technical Skills: Expertise in GxP validation practices, including IQ/OQ/PQ for equipment, facilities, utilities, and computerized systems (e.g., LIMS, MES, ERP). Proficiency in validation lifecycle management and risk-based validation approaches.

• Knowledge: Deep knowledge of regulatory requirements and guidelines, including FDA, EMA, ICH Q9, GAMP 5, and other global standards for computer systems and process validation.

• Skills: Strong analytical, problem-solving, and project management skills. Ability to lead cross-functional teams, manage multiple projects, and communicate effectively with stakeholders at all levels.

• Certifications (optional): ASQ Certified Quality Engineer (CQE), Certified Pharmaceutical GMP Professional (CPGP), or similar certifications in validation and quality are advantageous.

Working Conditions:

This role requires a mix of office-based work and time spent in manufacturing or laboratory environments, where adherence to safety and gowning requirements is necessary. Occasional travel may be required to support validation efforts at different sites.

Performance Metrics:

• Successful completion of validation projects on time and within regulatory standards

• Maintenance of audit-ready validation documentation and support for audit outcomes

• Contribution to continuous improvement in validation processes