Job Title

Lead or support cross-functional teams to evaluate, develop, and manage projects for new product development and ongoing lifecycle management of products, processes, and therapies. Oversee and manage operational aspects of ongoing projects, serving as a liaison between project management, planning, project teams, and line management. Develop, generate, and execute equipment and process validation protocols in compliance with company and regulatory requirements. Manage the development and implementation process of products and services, focusing on quality, schedule adherence, and project deliverables. Review project status, budgets, and schedules; prepare status reports and updates for stakeholders. Monitor project performance from initiation through completion, identifying and resolving issues to meet productivity, quality, and client-satisfaction goals. Gather and manage requirements to ensure alignment with stakeholder needs and regulatory expectations. Communicate effectively with stakeholders to ensure engagement and successful delivery of project objectives. Maintain accurate documentation of validation activities, deviations, and reports. Ensure compliance with all applicable quality, safety, and regulatory standards. Other duties may be assigned.

Experience: Minimum of 2 years of hands-on experience with equipment and process validation in a regulated industry (medical device, pharmaceutical, or biotechnology). Technical Skills: Generation and execution of validation protocols (IQ/OQ/PQ). Understanding of process characterization and validation lifecycle. Knowledge of statistical tools for sampling determination and process evaluation. Proficiency in project management and cross-functional coordination. Soft Skills: Strong analytical, organizational, and communication abilities; ability to manage multiple priorities and meet deadlines. Education: Bachelor's degree in Engineering, Life Sciences, or related field preferred.