Medical Device Packaging Engineer (Pharmaceutical Regulatory)

You are an expert in regulatory affairs especially in the area of medical devices?

Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!

Our client, an international pharmaceutical company (in Zuchwil, close to Solothurn), is looking for you!

This role supports manufacturing operations in the areas of process development, tool design, machine programming, machinery & equipment acquisition.

You will provide direction and technical support regarding equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem solving and report or presentation preparation.

Duties and Responsibilities:

- 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
- 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, etc.)
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

Candidate's Profile:

Linguistic background (MUST-HAVE):

- Fluent English
- German as advantage

Work experience (MUST-HAVE):

- 2 years' work experience in an adequate position and regulated industry preferred
- Experience in an Medical Device regulated environment
- Background on validation procedures and packaging technology
- Strong knowledge and skills in MS Office
- Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP will enhance candidacy

Education (MUST-HAVE):

- Bachelor's degree in business, information systems or related discipline, or equivalent and extensive related project experience.
- Certificates in Program/Project Management will enhance candidacy but are not a requirement

For further details please contact Aleksandra Sztajerowska:
E-mail: (see below)

Only English-written CV will be accepted.

Please note that only selected candidates will be contacted.