THE POSITION

Are you ready to play a pivotal role in ensuring the highest standards of quality at our Pirbright Site? As a Quality Validation Engineer, you will be at the forefront of our Quality Validation program, focusing on key areas such as Process Validation, Control Strategy, Cleaning Validation, and Hold Time Validation. You will also manage the planning and execution of overall Validation processes for the site.
In this critical role, you will lead the charge in ensuring our validation documentation meets GMP Regulations and Boehringer procedures/policies, fostering a culture of compliance throughout the organization. You will author, review, and execute validation and qualification lifecycle documentation while overseeing site validation activities. Additionally, you will develop and maintain standard operating procedures, stay updated on validation trends, and provide necessary training.
This is a hybrid role based in our manufacturing site in Pirbright.

REQUIREMENTS

• Educational Background: Degree in a related science or engineering field, or formal qualification in validation or quality
• Experience: 5+ years in equipment and process validation within a GMP pharmaceutical environment
• Project Management: Experience in project management is desirable
• Quality System Experience: Previous experience in a quality system environment, preferably within the pharmaceutical industry
• Validation Knowledge: Extensive knowledge of validation and qualification, including Equipment Qualification, Computer System Validation, Facilities and Utilities Validation, Cleaning Validation, and Process Validation
• Aseptic Production: Experience in aseptic production and biologics is desirable.
• Communication Skills: Excellent written and verbal communication skills, with experience in authoring technical documentation
• GMP Understanding: Strong understanding of current Good Manufacturing Practices (GMPs), Risk assessment, and Data Integrity.
• Collaborative Ability: Demonstrated ability to work collaboratively across functions

• Drive Process Improvements: Support operations in developing and delivering process improvements and projects, managing initiatives, and capital projects aligned with business needs
• Collaborate Across Functions: Work with all site functions to ensure compliance with local and BI directives
• Maintain Documentation: Create and maintain validation documents, Quality strategic documents, and ensure ongoing review of Site’s Control Strategies and regulatory compliance
• Manage Validation Documentation: Ensure protocols and reports (URS, FAT, SAT, IOPQ, Periodic reviews, etc.) align with regulatory and Boehringer requirements
• Generate KPI Reports: Produce monthly, quarterly, and annual KPI adherence reports for various projects and topics
• Ensure Validated Status: Work with all departments to maintain validated status of processes, manage validation project activities, and allocate resources
• Build Networks: Establish strong connections with local validation SMEs and Global MSOs
• Support Quality Management: Assist in Quality Management System activities such as audits, CAPA, Deviation, Change Control, investigations, and risk assessments
• Develop Documentation: Manage the development and modification of SOPs, Work Instructions, and guidelines for validation/compliance-related policies, ensuring alignment with BI Requirements and templates
• Stay Updated: Investigate industry trends in validation and compliance, and adjust programs to meet current requirements