Packaging Technical Transfer Principal Engineer – Johnson & Johnson – Schaffhausen, Switzerland

Cilag AG in Schaffhausen manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products and we have an impressive pipeline of new and innovative products.

Based in Schaffhausen we are looking for a highly committed

Packaging Technical Transfer Principal Engineer

The New Packaging Technical Transfer Principal Engineer has overall accountability to support the flawless and timely development and implementation of all packaging technical transfer activities from qualification through registration into validation/launch in the respective production site. The role is the point of contact and team representative to the site Technical Launch Integration team for all packaging integration and readiness activities for launch. The position holder will also sit on the New Product Team (NPT) as requested by the New Product Leader (NPL). This position will be part of the Corporate Global Packaging Engineering group based in the US.

Your main tasks will include

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Coordination of all packaging activities related to new product launches in accordance with current procedures and in collaboration with the site departments that are responsible for business launches and international launch management, quality, supply chain and affiliates

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Timely introduction of new products packaging, including coordination and tracking of all necessary shop floor activities, eg. Master Data and SOPs adaption, component/ equipment performance qualification protocol execution and reports, resource planning

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Coordination of activities related to the preparation of art work for printed materials as required by current procedures and regulations, in cooperation with the global graphics service organization and affiliates

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Coordination of qualification and validation process activities for packaging in regards to new product launches

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Conducting WIP (finished goods and Drog Product bulk) and finished Stock keeping Units (SKU’s) shipping validations for both physical and temperature protection as applicable both into and out of the distribution center(s)

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(This includes site-to-site shipping studies as appropriate)

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Close collaboration with local site and global J&J Business partners such as: QA/QC, Master Data, Product TLI (Technical Launch Integrator), PDMS (R&D Group) Primary Container, SCDL (Supply Chain Development Leader), Engineering, Finance, Suppliers, Planning, Text and Design, Production, Validation etc.

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Compliance assurance with regulations for packaging, including focus on safety, GMP and product quality

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Creating, editing and ensuring the maintenance of procedures and work instructions necessary for the performance of packaging activities

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Creating or adapting corresponding Master Data, recipes, SOPs for new products packaging and assurance of appropriate training and knowledge transfer

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The field of responsibility includes risk management for new product packaging, investigation of production issues with packaging, implementation of improved and state of the art control processes for early identification and avoidance of production related risks

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Manage other packaging projects/programs/activities such as new packaging equipment, serialization, sustainability, primary and secondary packaging design activities.

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Provides technical expertise to the New Product Teams (NPT) assisting with the resolution of problems associated with packaging/component equipment conflicts.

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Directs packaging technology efforts on several major projects concurrently.

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Coordinates both internal and external resources to complete projects.

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Recommends improvements to secondary packaging component design.

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Directs packaging material suppliers to new areas of innovation.

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For this responsible position we are looking for a person with thorough understanding of business requirements, effective communication, leadership and interdependent partnering skills.

Qualifications

Your profile

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A Bachelor’s / Master’s / PhD degree in Engineering is required; major in Industrial, Mechanical or Electrical Engineering preferred. A Packaging Material Science degree will also be considered.

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A minimum of 9-12 years of experience in the healthcare regulated industry

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Experience in packaging processes of pharmaceuticals, parenterals, devices or combination products is a must.

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Strong know how of regulatory requirements and GMP for pharmaceuticals

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Experience in cold chain and transportation qualification activities is highly desirable

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Experience should include management of equipment projects.

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The candidate should be familiar with global regulations regarding packaging.

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Has experience in developing primary and secondary packaging systems and specifications.

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Has experience in writing and executing protocols for testing packaging systems and validation of packaging systems including cold chain and transportation qualification.

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Good oral and written communication skills are required, as well as the ability to work on multi-disciplinary teams.

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Ability to handle multiple tasks and be willing to challenge existing practices and work with minimum supervision.

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A proven track record of successful projects and packaging tech transfer management

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Ability to foster collaboration within cross functional teams

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Ability to influence peers, superiors and external partners

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Proficiency in English and German

The selected candidate may be required to travel approximately twenty five percent (25%) of the time, to domestic and international destinations.

We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and an excellent infrastructure.

If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.

Primary Location:Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen
Organization: Cilag AG (8562)
Travel:Yes, 25 % of the Time
Job Function: Packaging

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