Job Description
Senior Packaging EngineerLocation: Ireland - CorkDepartment: Manufacturing Operations & Supply ChainType: RegularJob DescriptionAt Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination, and a relentless drive to make a difference.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfill their aspirations. Join Gilead and help create possible, together.The PositionThe Senior Packaging Engineer position is an exciting opportunity to become part of the Global Manufacturing, Packaging & Labelling Business Operations (MPLBO) organisation at Gilead. The Senior Packaging Engineer is a highly visible role and shall be primarily responsible for the New drug product launches, tech transfers of Oral Solid Dose (OSD) and Combination devices/assembly/kitting, CMO Packaging operations, Packaging COGS reduction projects and GMP documentation to support the development and implementation of packaging solutions for a range of Gilead products across the Gilead Manufacturing network. The Senior Packaging Engineer shall also be responsible for designing and conducting package testing and transportation studies for a range of pack formats, i.e., bottle, combination products and glass vial products including cold chain technologies. The Packaging Engineer shall be required to provide ongoing technical and operational support to Contract Manufacturing Partners (CMOs) globally and to contribute to the development of the packaging capabilities.Job duties include:Packaging Engineering & Operations:Support and/or lead the planning and execution of packaging projects for a wide variety of project types including but not limited to New Product Introductions, Tech Transfers, Quality Workstreams like RCA/Deviation/CAPA management, Supplier Changes, Cost Savings Initiatives at multiple internal and external packaging sites.Support and/or lead external packaging operations for Contract packaging site(s) in the EMEA region. Prior CMO Management experience in EU is essential.GMP documentation and packaging systems expertise to efficiently manage change controls, packaging & labelling specifications, technical documentation/reports etc.With minimal guidance, determines the functions most critical to departmental success and supports priorities accordingly.Position requires technical knowledge of packaging materials, processes, qualification & validation requirements in high volume manufacturing set up.The Senior Packaging Engineer will work closely with multiple internal and external stakeholders including Quality, Validation, Regulatory, Labelling Operations, Supply Chain, CMO Management and Packaging Suppliers.An understanding of Packaging Lifecycle Management software/systems to manage documentation workflow is an advantage.Device and Kit Assembly:Support and/or lead the engineering, operational and testing of secondary packaging presentations for combination devices/kits to achieve project deliverables.Accountable for developing innovative, creative, and cost-competitive secondary packaging/kitting solutions that meet the needs and requirements of our patients, environment friendly, and in line with our quality standards.Understanding of major regulatory requirements, to support review of regulatory submission documents, plans, protocols, and reports etc.Influence understanding and interpretation of packaging regulations.Represent MPLBO as a specialist on Device Projects, ensuring the voice of customer is captured during strategic discussions.Position requires basic understanding of Serialization requirements such as EU FMD, DSCSA and other serialization/aggregation processes.Project Management:The Senior Packaging Engineer shall support packaging projects and will be required to follow global guidelines on project delivery throughout the project lifecycle, project business cases, project charters, project scheduling, progress reporting.Use change control systems and project governance policies & systems.Collaborate with on-site and off-site stakeholders to support global initiatives and projects.Cost Efficiency and Continuous Improvement:Lead and oversee approved cost savings projects across the sites and CMOs to meet the near- and long-term Cost efficiency targets.Analyze packaging engineering processes and documentation practices to identify and implement continuous improvement initiatives.Knowledge, Experience and Skills:Degree in Packaging/Device/Quality Engineering or related field essential.Extensive experience within the pharmaceutical, biotech or related industry.Strong technical and scientific skills with proven experience in the development of packaging solutions for OSD, parenteral and/or device packaging.Demonstrates strong knowledge of cGMP & regulatory processes.Experience of primary and secondary packaging processes, device and kitting assembly process, transportation studies, qualification/validation is essential.Project Management and Stakeholder management experience is essential.Strong communication, teamwork and organizational skills are essential.Demonstrates excellent verbal, written, and interpersonal communication skills.Behaviours:Ability to engage and partner with multiple stakeholders to achieve the objective.Curious with learning agility.Operationally excellent.Organised with systematic approach to prioritisation.Process orientated to achieve the business objective. #J-18808-Ljbffr