Job Description
Catalyx is seeking a Packaging Project Manager to work on our customer site based in Cork. Who We Are : Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processesgloballywith a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyxs partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. The Role: The Packaging Launch Specialist reports to the Packaging Project Lead and works in a team environment that will be committed to continuous improvement, process understanding, personal development and demonstration of production techniques that will result in agile and compliant packaging operations. Main Areas of Responsibility: Co-ordinating new product launches for the current site, for example Voxzogo DCC launch Managing multiple market launches for existing products in the current site (approx. 50 60 per year), including Palynziq, Voxzogo, Vimizim, Naglazyme. Our site representative at global launch forums, ensuring adherence to product launch plans and the production schedule. Lead and demonstrate strong stakeholder management in terms of interfacing with other departments on site and global teams (Material Operations, Capital Projects, Process Engineering, Quality, Packaging Development, Product Artwork Team, MES, ) Implement a site launch management process, utilizing six sigma tools to identify opportunities for improvement Support and partner closely with peer groups to ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions ensure Manufacturing systems and practices are consistent throughout the organization Partner with subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for Commercial Packaging Operations. Operational support potential/ as required Supporting: RCARs Continuous Improvement Initiatives & Capital Projects Comply with cGMP Documentation & Operations Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance. Skills Demonstrated experience in a cGMP environment Past experience and demonstrated ability to deliver projects to tight timelines Lean six sigma experience preferred Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional Education Degree in science/engineering, operations management or industrial engineering required Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework) Experience At least 3-5 years experience in a regulated manufacturing environment with excellent knowledge of packaging operations Proven project management experience with track record of delivering projects to tight schedules Familiarity with project management systems, e.g., Excel, Microsoft Project, etc. Demonstrated ability to partner with other functional groups to achieve business objectives Strong knowledge of cGMPs (US & EU), ISO, ANSI and other regulatory agency standards and requirements applicable to packaging operations Experience of successfully contributing to a start-up operation highly desirable Strong communication and interpersonal skills oral, written and formal presentation skills Creative problem-solving skills Why Join Catalyx? At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. Skills: Packaging Design Product packaging