Koch
Join our Talent Network
Skip to main content

Packaging Engineer

This job posting is no longer active.

Description

Do you want to part of developing state of the art manufacturing solutions for medical devices, helping patients to get better treatment?

Are you ready to lead cross-functional projects, delivering on time and quality to clients’ satisfaction?

Do you want to cooperate with highly skilled colleagues to bring new products to market in a fast-growing and successful global company?

Then you may be the Packaging Engineer we are looking for in Phillips-Medisize’s Global Innovation & Development Center (Virum or Struer).

 What You Will Do In Your Role

  • Responsible for the Labelling and Packaging process from Development to commercial production.
  • Domain Specialist support during development (design), verification, validation and implementation of packaging designs including serialization
  • Review and approve development documentation on labelling/Packaging
  • Clarify Technical Requirements and Specifications for packaging components and concepts
  • Review and approve engineering drawings and tolerance calculations for packaging materials
  • Develop, execute, and report verification methods and testing in cooperation with external partners
  • Participate in technical and design reviews for combination products
  • Responsible for transfers from development to manufacturing – translation of design outputs into production specifications
  • Ensuring Labelling setup in SAP, MII and printers
  • Coordinate Label development internally with Molex org.
  • Ensure documentation for biocompatibility is available & up-to-date (REACH, ROHS, California Prop. 65, …). Support submission by providing compliant and comprehensive packaging/labelling overview.
  • Support update of packaging, labeling, and Instruction For Use (IFU) as part of commercial launch
  • Coordinate packaging development with external partner and costumers
  • Clarify requirements with costumers and coordinate though product launch
  • Write and/or review regulatory documentation for packaging
  • Lead root cause analyses for failures for commercial packaging
  • Collaboration with RA and HFE ensuring compliance 

The Experience You Will Bring

Requirements:

  • Bachelor’s or Master’s Degree combined with years of experience from working with secondary packaging development, product transfers, product maintenance and manufacturing
  • Familiar with applicable regulations and standards (e.g. 21 CFR 210/211/820/, EMA scientific guidelines on the packaging of medicinal products, ISO 14971, ISO 13485)
    • Ability to work independently and across functional teams
    • Background and experience in working with external partners
    • Broad technical understanding
    • Ability to read, analyze and interpret technical procedures, or governmental regulations
    • Strong problem-solving skills
    • Capability to advance multiple projects in a fast-paced environment
    • Experience in System and Risk Management Engineering
    • Experience in design control, change control and deviation handling
    • Understanding of the applicable manufacturing/testing processes Drug Product Secondary Packaging and manufacturing processes
    • Advanced user of MS Office, Access and other relevant IT tools or systems.
    • SAP on advance level and MII knowledge is an advantage 

    Phillips-Medisize A/S is an expert in the design, development, and delivery of advanced drug delivery devices and connected health solutions. The customers are leading pharmaceutical companies worldwide. Phillips-Medisize A/S is a part of Phillips-Medisize the Pharmaceutical and Medical Division of Molex. The company offers innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Read more about Phillips-Medisize A/S at phillipsmedisize.com


    #LI-IB1

    This job posting is no longer active.

    Sign up for our talent network.

    Not ready to apply? Take a minute to sign up to receive notifications on opportunities that match your interests.

    Sign Up Now