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Packaging Engineer / Senior Packaging Engineer

Company: Ultragenyx Pharmaceuticals
Location: novato
Posted on: May 3, 2021

Job Description:

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives.

Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include WebEx video discussions, interviews & onboarding.

Position Summary

ultrainnovative - Tackle rare and dynamic challenges

The Packaging Engineer / Senior Packaging Engineer will provide technical direction for the development, qualification and deployment of packaging structures and packaging lines. This activity involves close cooperation and collaboration with internal teams as well as Contract Organizations (CO) to deliver innovative packaging solutions to meet patient and business needs.

You will prepare protocols and reports for packaging feasibility and validation activities. You will have expertise in component and packaging line design, qualification methodology, serialization, packaging optimization, CO and vendor relations, and packaging ASTM/ISTA test methods. You will manage Medical Device manufacturing inclusive of design, testing, qualification and CO management.

You will be part of the Global Packaging Operations performs identification, validation and qualification of processes and components and manages the production for Clinical and Commercial products. This is inclusive of primary packaging, secondary packaging and medical devices.

Responsibilities including, but not limited to:

* Manage medical device (Class I and II) manufacturing inclusive of design, testing, qualification, and Contract Organization management. * Develop and qualify primary and secondary packaging solutions for products throughout the product lifecycle * Evaluate and select packaging materials, equipment or packaging systems based on patient and business requirements * Provide Clinical with packaging options that best meet the needs of the clinical trial design * Establish packaging structures/specifications for clinical and commercial use * Ensure compliance with global regulations * Troubleshoot packaging problems, document findings and implement solutions to resolve issues including complaints * Validation oversight for packaging lines (primary to tertiary) * Oversee validation operations at sites as Person in Plan Medical Device supplier identification and manufacturing management (production/testing/qualification) * Manage quoting, contracting, and budgeting as related to CO packaging and testing activities * Provide technical and document management support and oversee validation work at CO's as related to packaging production and integration of new processes or equipment * Oversee the Stability Program for primary, secondary and tertiary components in collaboration with the Packaging Design Management team * Participate in vendor selection process of packaging CO's * Systems support for Artwork Management and Serialization * Author Regulatory Submissions

Requirements:

* Bachelors' degree, preferably with an engineering degree in packaging, materials science, chemical, mechanical, or a related field. * 5+ years working in packaging development lifecycle activities in the Pharmaceutical or Medical Device industry. * Medical Device experience preferred. * Medical Device experience preferred (Medical Device Class I and II) * Continuous improvement experience e.g. Lean, Six Sigma * Project management skills and experience leading cross-functional projects * Knowledge of testing methodologies and test standards as well as knowledge regarding design control, documentation, risk management and processes * Experience in packaging technology (e.g. vials, pre-filled syringe, devices, bottles, blisters, labels, cartons, ultra-cold requirements, etc.) and printing systems * Development of qualification protocols/reports for packaging and shipping qualification activities * Problem-solving, decision-making, negotiation and influence. * Strong interpersonal skills, flexibility and the capacity to manage fast-paced changes in a team environment. * Exceptional verbal and written communication skills * Experience with key software tools: such as SharePoint, Smart Sheet, OneNote, TOPS, Word, Excel, PowerPoint, Project, Visio * Experience with Change Control systems * Familiar with Graphic Arts development * Proficient in Esko ArtiosCAD, Palletization Software, SolidWorks or equivalent CAD software. * Knowledge in package performance testing standards, i.e. ASTM D4169 and ISTA 2A * Travel: 10-20%

#LI-CV1

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

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Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.

Keywords: Ultragenyx Pharmaceuticals, Novato , Packaging Engineer / Senior Packaging Engineer, Other , novato, California

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