Packaging Engineer

Posted 25 November 2021
Job type Limited
DisciplineLife SciencesEngineering

Job description

For our client, a leading international pharmaceutical company, we are currently looking for a new team member as a:

Packaging Engineer

Overall Responsability

  • 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

Position Duties and Responsabilities

  • 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.
  • Establishes and tracks critical milestones, timelines and contingency plans
  • Follows up throughout project process to ensure project goals are achieved
  • Seeks out continuous improvement opportunities and oversees 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.
  • Responsible to originate/oversee/assist in the creation & release of change orders (COs) for shelf life 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.
  • Additional duties as assigned.
  • 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.

Professional Experience Requirements

  • at least 4 years' work experience in an adequate position and regulated industry preferred
  • Experience in an Medical Device regulated environment, package qualification or quality eng. department a plus
  • Proven exceptional written and oral presentation skills

Educational Requirements

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

Other Requirements

  • Strong knowledge and skills in MS Office
  • Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP will enhance candidacy
  • Must be highly organized, creative, articulate and analytical
  • Strong interpersonal and diplomatic skills
  • Ability to multi-task independently with minimal supervision
  • English spoken and written

Workplace: Zuchwill

Workload: 100%

Start Date: asap

Duration: 1 year

Your Application

Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).