Senior Packaging engineer in Schaffhausen

veröffentlicht
Kontakt
Lucie Nasshan, Basel Professionals Health Care & Life Sciences
Jobtyp
Temporary
jetzt bewerben

job details

veröffentlicht
Ort
Schaffhausen
Sektor
Life Sciences
Jobtyp
Temporary
Referenznummer
12356
Kontakt
Lucie Nasshan, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50
jetzt bewerben

Stellenbeschreibung

Randstad Professionals is currently looking for a Senior Packaging engineer  who will be assigned an interesting challenge for a major client based in the canton of Schaffhausen.

This contract is an unique opportunity to join a major client, lead player in the pharmaceutical indutry.

The initial assignment will start in April and will last until December 2019.  

Main objective :

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 packaging sites and external contracting sites, as applicable.

Your key responsibilities will include:

Lead or contribute to the following:

  • 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.

The following skills are required:

  • Candidates shall have broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing products.

  • English fluent is a must and German is an important advantage.

  • 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.

  • 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.

The following education requirement are mandatory:

  • This position will require a minimum of a bachelor’s degree in Engineering or related discipline or equivalent combination of education and work experience.

  • Candidates who possess a degree in Mechanical, Biomechanical or Materials Engineering are preferred. Candidates who possess a process excellence certification are also preferred.

  • This position requires a minimum of 3 years of packaging engineering and/or design, or relevant experience is required.

Expertise in the following systems is required:

  • 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 statistical techniques when analyzing data and make rational and logical decision based on that analysis.