Senior Packaging Engineer Apply
locations: Ireland - Cork
time type: Full time
posted on: Posted 30+ Days Ago
job requisition id: R0042466
Job Description Senior Packaging Engineer I, Cork Description: The 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 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 specialist on Device Projects, ensuring the voice of customer is captured during strategic discussion. Serialisation & Aggregation 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. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
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