Position Title:  Validation Engineer

Purpose:

Ensure manufacturing process (including equipment, methods) and Local RRP Computerized Systems are appropriately qualified and validated while conducting review of related documentation and leading quality risk assessment and change management activities. Consistently apply OPEN+ systems and tools.

Accountability 1 SUSTAINABILITY

Ensure compliance to all PMI and legal standards, policies and guidelines related to Environment, Health, Safety, Sustainability to prevent personnel, asset or societal loss. Act and promote an interdependent and transparent safety culture fostering the utilization of preventive/predictive approach in line with Open+/IOS.

Accountability 2 QUALITY VALIDATION ACTIVITIES

Lead and execute validation activities that are identified and required. Prepare all the documentation associated by ensuring the execution following the plan. Ensure that all validation activities are carried out and reported in a timely manner. Ensure that all deviations during validation activities are investigated and escalated when required. Propose action plans and ensure that correctives/preventives actions are followed and closed on time. For Local RRP Computerized Systems review user, functional and technical specifications. Develop test plans, coordinate and supervise testing phases and manage issues. Review test scripts for functional testing, regression testing and load testing. VALIDATION SUSTAINABILITY Organize and lead the Continued Verification Assessment and the re-execution of validation protocols according to the plan and procedures. Provide reports and other documentation associated with validations, as appropriate for each validation exercise. CHANGE MANAGEMENT Lead and coordinate change management process in the factory and ensure validated state of the manufacturing processes, methods and systems is maintained. Ensure the reporting and the update of key metrics. Perform Risk Assessment for system changes. RISK-ASSESSMENT Provide support and act as SME / Facilitator for the Quality Risk Assessment. Ensure the appropriate methodologies are implemented and mitigation plans defined and followed up by the relevant responsible persons as per established quality requirements. COMMUNICATION & PROJECT Provide full support by sharing expertise and knowledge to business owners and relevant stakeholders. Through effective communication and training initiatives, develop cross-functional and cross-departmental staff (in projects and validation teams) to ensure that validation projects are carried out in accordance with internal Policies and Procedures. Ensure compliance through assisting in audits. Participate in reviews in all phases of the software development cycle. Support Project and Operation teams in relation to CSV worldwide. QMS SUPPORT Participate to the creation/update of procedures, work instructions and others Quality Documents that are required. Provide support and training by ensuring a transfer of knowledge according to the training management system. Contribute to overall CSV best practices, strategy and methodology. Recommend process upgrades and efficiency improvements and implement them.

Education College/University Honours / Masters degree in Biological sciences, Physical sciences, Chemistry, Engineering or equivalent education

Work Experience 3-5 years experience in quality assurance in tobacco, food, pharmaceutical or similar industry and/or 3-5 years experience as a specialist in a relevant area of activity.

Language Skills Local Language: Fluent, English: Fluent