Project Engineer

Schaffhausen  ‐ Vor Ort
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Beschreibung

Project Engineer - Schaffhaussen - 100%

Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.

For our international client based in Schaffhaussen, Experis is currently looking for a Project Engineer for a contracting position of 1 year.

General information:

Start Date: 15.02.2018

End Date: 15.02.2019

Work Location: Schaffhaussen

Work Load: 100%

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 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, 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.

You bring for this role the following qualifications:

  • 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 is required.
  • Knowledge of temperature control/cold chain distribution and its application to pharma & medical device products is preferred.
  • In addition this position requires project management skills, as well as interpersonal communication skills
  • minimum of a bachelor's degree in Engineering or related discipline or equivalent combination of education and work experience.
  • Process excellence certification is preferred.
  • Minimum of 3 years of packaging engineering and/or design, or relevant experience is required.
  • Fluent in written and spoken English. German is a surplus.
  • Demonstrated experience in complying with one or more of the following is required: FDA CFR part 3, 4, 210, 211, and 820

Interested in this opportunity?

Kindly send us your CV today through the advert. However should you have any questions please contact Stéphanie Vogt.

Even though this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland.

Start
15/02/2018
Dauer
12 months
Von
Experis AG
Eingestellt
25.01.2018
Projekt-ID:
1490898
Vertragsart
Freiberuflich
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