Validation Lead

1 week ago


Waterford, Ireland Cpl Resources - Cork Full time

Responsibilities: Leads and fosters collaboration across Operations, Technical, Quality, Logistics, Finance, and Engineering teams at the site level, while liaising with R&D and other key stakeholders beyond the site. Oversees project execution and ensures the smooth transfer of technical processes into the site. Drives the launch of new products from R&D, Line Extensions, and Geo-expansion introductions, focusing on project and risk management, technical due diligence, and embedding quality and capability to develop and implement reliable, cost-efficient manufacturing processes. Evaluates opportunities from business and technical perspectives to determine feasibility, conducting Site Impact Assessments (SIA) with input from relevant site functions to summarize site capabilities, required investments, cost estimates, and timelines for potential transfers. Works in tandem with Site Technical teams and other functions to ensure product development meets quality and process capability standards defined in collaboration with commercial and R&D teams, using appropriate business acceptance criteria. Oversees and allocates resources to Project Managers for planning and executing various project types (e.g., NPI, VE/PPV, line extensions, and complex site initiatives). Develops project plans, secures necessary resources, monitors adherence to timelines, and creates contingency plans for low-complexity projects. Ensures risk mitigation strategies are established and aligned with Site/Regional Quality Councils. Builds and supports project teams, ensuring effective communication flows from the team to the SLT and the broader organization. Escalates and communicates risks appropriately within the organization. Required Skills & Experience: BS degree in Science, Engineering, or Business Administration. At least 5 years of proven experience in regulated environments (HPRA/SGS/FDA), including manufacturing, product introduction project management, or R&D product development. Demonstrated expertise in the FMCG or Pharmaceutical sector, with a focus on leading technical aspects of new product launches, technology transfers, risk assessments, product control strategies, validation, and change control. PMP certification or an equivalent qualification is preferred. #LI-KO4 Skills: validation management risk


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