@Biocartis_

Labelling, Packaging and Technical Data Expert

Mechelen / 2016052
Contact

Biocartis NV; email: HR@biocartis.com

Function Type
Full-time
Experience Required
  • At least five years’ experience working in a regulated environment is a must. Preferably having worked within a new product development environment or within lifecycle management.
  • Ideally experienced in the design and development of medical devices or in-vitro diagnostic equipment working within an ISO13485 / GMP compliant environment.
  • Proven experience with product data management systems is an asset, ideally Team center PLM.
  • Proven experience with 2D drawing programs, preferably Adobe Illustrator.
  • Knowledge about printing process is asset.
  • Experience with 3D CAD systems is an asset, ideally NX.
Education

A Bachelor degree in a technical/ pharmaceutical orientation or equivalent through experience.

Functional Area
Product Engineering
Travel Percentage
0-5

Purpose of the position:

  • The Labelling and Packaging Expert will take responsibility for the realization of all product labelling and packaging associated with the Biocartis platform products.
  • Close cooperation with the Technical writing team.
  • This role extends to product lifecycle management of Labelling from writing a Change Request, creation of the labelling artworks and material specifications, the review and approval of all product labelling proofs, and updates to previously released product labelling. During the realization process, the Labelling and Packaging Expert will be expected to create/ outsource the design and work closely with all stakeholders.
  • The Labelling and Packaging Expert is expected to manage the realization of Labelling and packaging deliverables in accordance with agreed schedules and quality expectations.
  • For labelling and packaging produced internally within Biocartis the Labelling and Packaging Expert will work closely with the Process Engineering team to ensure that the labels are generated in accordance with the design specifications and process capabilities.
  • The Labelling and Packing Expert will support the whole life cycle management, working with vendors to ensure receivables are in place, qualification is executed according to protocols, reviewing labelling proofs, and initiating supplier corrective actions when required.
  • The role requires close cooperation with the Marketing function to establish product specifications in line with customer expectations.
  • The Labelling and Packaging Expert will work alongside Technical data documentation administrator to assure that the Biocartis Technical Product Data is stored and maintained and is accessible for engineers and other stakeholders.

 

The Labelling, Packaging and Technical Data Expert is a member of the Platform Design team.

 

Tasks/outcome domains

  • Responsible for the creation, review and maintenance of all product Labelling documentation for Biocartis products (e.g. Instrument, Console and Cartridge). This includes all product labels and packaging elements.
  • Responsible for creation of Labelling and packaging related change requests, implementation plans, change execution and closure of change requests.
  • Works closely with technical authors, system engineers, marketing, quality and regulatory teams to establish product Labelling content, format and compliance requirements.
  • Supports in the selection and qualification of external suppliers for product Labelling and Packaging.
  • Manages packaging (re-) design and qualification alongside suppliers and Biocartis stakeholders, such as Process Engineering, Marketing and Quality Assurance.
  • Creates/ outsources the appropriate artworks and technical Labelling documentation to support the supply of all product labels and packaging.
  • Reviews and approve label proofs for product Labelling (or perform first article inspections if necessary).
  • Manages the product Labelling review and approvals process within the Biocartis change management process.
  • Works with Biocartis process engineering teams for the creation, approval, release and maintenance in-house printed packaging.
  • Assures that labelling and packaging technical data is maintained stored and revision managed in the Product Data Management system (Team center PLM).
  • Assures that Labelling and packaging technical data is accessible for all stakeholders.

 

Profile and competencies

  • A Bachelor degree in a technical/ pharmaceutical orientation or equivalent through experience.
  • At least five years’ experience working in a regulated environment is a must. Preferably having worked within a new product development environment or within lifecycle management.
  • Ideally experienced in the design and development of medical devices or in-vitro diagnostic equipment working within an ISO13485 / GMP compliant environment.
  • Proven experience with product data management systems is an asset, ideally Team center PLM
  • Proven experience with 2D drawing programs, preferably Adobe Illustrator
  • Knowledge about printing process is asset
  • Experience with 3D CAD systems is an asset, ideally NX
  • Time management : Responsible for organizing own time in an optimal fashion.
  • Highly accurate, eye for detail.
  • Analytical thinking.
  • Persistent, will follow through.
  • Good communication skills.
  • Team player with well-developed interpersonal skills.
  • Proactive approach and able to work autonomously
  • Able to work with (tight) deadlines.
  • Able to work with different stakeholders.
  • Problem solving attitude.
  • Scientific integrity.
  • Excellent knowledge, orally and in writing of English.
  • Knowledge of Dutch is an added value.
  • MS Office, Adobe Illustrator, CAD and PDM software.

 

Our offering

We offer you an exciting job in a fast growing international and innovative environment where you can work with top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team. You will have freedom to shape your work and shape your job where you deem it necessary: we value your input. Of course we offer you an appropriate compensation package.

 

Interested?

Please apply by e-mail and send your CV and motivational letter to HR@biocartis.com  using the job ID 2016052 as a reference.  

Deadline for applications is 16 February 2017.

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