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Packaging Engineer- Senior

  • Gehalt: CHF65 - CHF75 per hour
  • Art der Stelle: Contract, Full-time
  • Ort: Schaffhausen
  • Berufsbereich: Other
  • Datum der Ausschreibung: 18.02.2019
  • Job ID: BBBH98194
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Senior Packaging Engineer

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

One of our clients, a leading Medical Device company in Switzerland, is looking for a Packaging Engineer. This is a challenging 9-month contract located in Schaffhausen, Switzerland.

Job Summary

You will provide support to technical design and standards for packaging equipment, secondary/tertiary packaging technical transfer and new product launch projects for all the packaging sites and external contracting sites. Including secondary/tertiary packaging design, material qualification, transport qualification; including cold chain, qualification of packaging manufacturing equipment and design transfer activities for combination products, vials and solid dosage forms.

Your tasks & responsibilities

  • Collaborate on Packaging/Technical Operations initiatives
  • 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 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, Technical Design Requirements, risk/criticality assessment and procedures for bulk and finished drug product
  • Authoring of Technical Development/Transfer Plans for Secondary/Tertiary Packaging project
  • Prepare/oversee 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
  • Resolve 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

What you must have

  • Bachelor's degree in Engineering or related discipline/equivalent combination of education and work experience.
  • 3 years of packaging engineering and/or design, or relevant experience
  • Experience in complying with one or more of the following: FDA CFR part 3, 4, 210, 211, and 820. Experience with FDA regulated Design Control, Change Control, CAPA, and ISO 13485
  • Able to use statistic techniques when analysing data
  • make rational and logical decision based on analysises
  • Broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing products.
  • Knowledge of Packaging Equipment is required
  • The ability to interpret engineering drawings is required
  • Secondary/ Tertiary Material packaging experience is required, Primary packaging material is a plus, package equipment qualification/validation knowledge is a plus
  • Understanding of cGMP, Good Documentation Practices, and Regulations
  • Able to lead and/or support multiple projects simultaneously is required
  • Able to perform root cause investigations and write technical documents
  • Project Management skills & interpersonal communication skills
  • Fluent English

What is nice to have

  • Degree in Mechanical, Biomechanical or Materials Engineering
  • Certification in Process Excellence
  • German
  • ICH and industry technical standards relative to Combination Product development
  • Knowledge of temperature control/cold chain distribution and its application to pharma & medical device products

Overview

  • Start date: 01.04.19
  • End date: 31.12.19
  • Work location: Schaffhausen
  • Workload: 100%

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Alexander Russell on +41 61 282 22 16, at www.linkedin.com/in/alex-russell-experis/ or via email

To view more jobs in Basel, visit https://www.experis.ch/it-jobs-in-basel

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