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Packaging Engineer

  • Salaire: CHF68 - CHF78 per hour
  • Type d'emploi: Contract, Full-time
  • Lieu: Schaffhausen
  • Secteur: Other, Pharma & Life Sciences
  • Date de mise en ligne: 02/10/2017
  • Référence du poste: J375048AJMK-021017

Packaging Engineer

Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.

For one of our client, specialized in medical devices based in Schaffhausen, we are looking for a Packaging Engineer with experience in a regulated environment

This is a challenging contracting position starting in November until the end of October 2018 with extension possibilities.



Tasks & Responsibilities
:

  • Collaborate on Packaging and/or Technical Operations initiatives as required, based on business needs.
  • As required, design and develop secondary/ tertiary packages for optimal equipment and process compatibility, considering patient/end user preferences and limitations.
  • Provide technical input for primary packaging equipment, materials and packages to the PDMS team in order to assure compatibility between primary and secondary packaging processes.
  • Design transfer /technology transfer/commercialization activities including process and equipment qualification (IQ/OQ/PQ).
  • Collection of design transfer documentation for consideration within the Design History File
  • Review and approve the following packaging documents: packaging component specifications, Packaging Bills Of Materials, Packaging component drawings, design history files (for combination products), Technical Design Requirements (TDR's), risk/criticality assessment and procedures for bulk and finished drug product.
  • Authoring of Technical Development/ Transfer Plans for Secondary/ Tertiary Packaging project.
  • Preparation and oversight of packaging development activities including preparation and organization of transportation studies.
  • Provide support to physical & cold chain shipping studies, line trial, packaging material qualifications, child resistant requirements, human factor studies and patient centric design.
  • Achieve timely resolution of secondary packaging project related operational deficiencies, as required.
  • Participates in risk remediation/reduction and drive toward root cause and robust corrective action/preventative action to improve process reliability.

Requirements:

  • Bachelor degree in Engineering or related discipline or equivalent combination of education and work experience
  • Minimum of 3 years of packaging engineering and/or design, or relevant experience
  • Knowledge of packaging equipment is required
  • Ability to interpret engineering drawings
  • Secondary/ Tertiary Material packaging experience is required
  • Primary packaging material is a plus
  • Understanding of cGMP, Good Documentation Practices, and Regulations is required.
  • Knowledge of temperature control/cold chain distribution and its application to pharma & medical device products is preferred.
  • Demonstrated experience in complying with one or more of the following is required: FDA CFR part 3, 4, 210, 211, and 820. Also ICH and industry technical standards relative to Combination Product development are a plus.
  • Experience with FDA regulated Design Control, Change Control, CAPA, and ISO 13485,
  • The ability to use statistic techniques when analyzing data and make rational and logical decision based on that analysis.
  • The ability to lead and/or support multiple projects simultaneously is required.
  • The ability to perform root cause investigations and write technical documents.
  • In addition this position requires project management skills, as well as interpersonal communication skills.
  • Fluent in written and spoken English. German is a plus

Location: Schaffhausen

Start Date: 01.11.2017

If you are a result oriented Packaging Engineer currently looking for a challenging new position that applies to your skills, then we look forward to receive your application!

I'm always looking for skilled Engineer please don't hesitate to send me your CV. You can also check my page: www.experis.ch/julie-mackerer to see all the positions I'm recruiting for or just connect with me on LinkedIn https://ch.linkedin.com/in/juliemackerer


Not the right job for you? Since new jobs are coming in every day just give us a call +41 (0)61 282 22 17. Experis, the leading IT recruitment agency in Switzerland has many open jobs, just browse our website now to find interesting professional opportunities!

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