Packaging Engineer (Medical Devices) (m/f/d)

REFERENCE NUMBER:

583132/1

MY DUTIES:

- Ensure availability and correctness of packaging documentation for sterile and non-sterile medical devices, in compliance with all valid regulations (ISO, MDR, FDA, etc.)
- Check packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life) in PLM/ERP systems and verify their correctness
- Perform updates/changes (DCR/DCO) for non-conforming packaging documents and Bill of Materials in the systems (Agile/SAP/Windchill)
- Support Shelf Life activities and create/update shelf life specific documentation for Eu and US
- Review and update technical reports, procedures, policies and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements and current technology
- Plan, schedule and track project timelines using appropriate tools
- Establish and track critical milestones, timelines and contingency plan
- Follow up throughout project process to ensure project goals are achieved
- Seek out continuous improvement opportunities and oversee timely implementation of efficient manufacturing practices
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) for all packaging related change requests through Agile PLM software
- Technical understanding (drawings, processes, packaging specifications and materials, validation standards (ISO11607, ISTA3A, ASTM standards for testing…) etc.)
- Initiate, route, verify and handle all the administrative paperwork and formalities in coordination with multiple departments stakeholder contacts

MY QUALIFICATIONS:

- Experience in an adequate position and regulated industry
- Experience in an Medical Device regulated environment, package qualification or quality eng. department a plus
- Bachelor’s degree in engineering or related discipline
- Certificates in Program/Project Management are a plus
- Strong knowledge and skills in MS Office
- Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP are a plus
- English fluent and spoken is an absolute must, German is an asset

MY BENEFITS:

- A very renowned company
- Fascinating, innovative environment in an international atmosphere

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.