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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
- 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
This job posting is no longer active.