Packaging Engineer in Schaffhausen

veröffentlicht
Kontakt
Catherine Schubert, Basel Professionals Health Care & Life Sciences
Jobtyp
Temporary
jetzt bewerben

job details

veröffentlicht
Ort
Schaffhausen
Sektor
Life Sciences
Jobtyp
Temporary
Referenznummer
11143
Kontakt
Catherine Schubert, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50
jetzt bewerben

Stellenbeschreibung

Our client, a leading international company, is looking for an 

                                                 Packaging Engineer

Location: Schaffhausen, Switzerland

Contract: until 31.12.2018 with a possibility of extension

Start Date: asap

 

Purpose of the function:

The Senior Engineer will provide packaging engineering support to technical design and standards for packaging equipment, secondary/ tertiary packaging technical transfer and new product launch projects for all of the packaging sites and external contracting sites.

Responsibilities:

  • 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 (TDR’s), risk/criticality assessment and procedures for bulk and finished drug product
  • Authoring of Technical Development/ Transfer Plans for the 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
  • Participates in risk remediation/reduction and drive toward root cause and robust CAPA's to improve process reliability 

Skills and Competencies:

  • Candidates shall have broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing products. 
  • Secondary/ Tertiary Material packaging experience is required, the 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 
  • The ability to perform root cause investigations and write technical documents
  • Very good project management skills, as well as interpersonal communication skills
  • Min. Bachelor’s degree in Engineering or min. 3 years experiences in an equivalent combination of education and work experience 
  • Candidates who possess a degree in Mechanical, Biomechanical or Materials Engineering and who possess a process excellence certification are preferred
  • Min. of 3 years of packaging engineering and/or design, or relevant experience is required
  • Min. 3 years experiences with FDA CFR part 3, 4, 210, 211, and 820
  • Experiences with ICH and industry technical standards relative to Combination Product development are a plus
  • Min. 3 years experience with FDA regulated Design Control, Change Control, CAPA, and ISO 13485
  • You have to be fluent in German and English

 

We are looking forward to receiving your application:

  • your CV in English
  • latest Work Certificates
  • your Motivation Letter  
  • ID/passport copy
  • Copy of Work Permit

Apply now to be considered!

For more information, please contact: Catherine Schubert, LS Recruiter, T +41 58 201 55 54, catherine.schubert@randstad.ch