5 days ago

Commercialization Packaging & Device Expert

Harvey Nash AG

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Commercialization Packaging & Device Expert


For our Clients in Basel we are looking for Commercialization Packaging & Device Expert for a 6 months contract.

Duration: 2018-02-01 to 2018-07-31


Workload: 100%

Role Purpose

  • Manages Device & Secondary Packaging activities related to transfer and launch for assigned projects.
  • Leads BTDM project team for transfer and launch project related to device assembly and secondary packaging processes within the BTDM manufacturing network.
  • Liaises efficiently with related global functions, in particular Device Development BTDM, TechOps, Regulatory and Supply Chain.
  • Is responsible for successful launch / transfer of assembly and packaging processes from Development into Commercial operations and for the availability of launch supplies (in time and in required quantities).

Major Accountabilities

  • Maximizes project value.
  • Provides technical expertise from commercial point of view during device development stages and process commercialization.
  • Supports Launch Site Decisions at e.g. PAC (Post Approval Commitment) by providing analysis of technology, capacity, skills by performing interfunctional evaluations. Makes recommendation to PAC for assembly & packaging site selection.
  • Manages technical launch activities (process, technology, capacity, resources) for assembly and packaging at involved sites.
  • Defines and monitors project scope and timing.
  • Assures that all activities are performed according to current processes and standards (GMP, HSE, Regualtory). Ensures PAI (Pre-Approval Inspection) readiness.
  • Is a member of the BTDM (Biologics Technical Development & Manufacturing) Device Development subteam, Validation team and Supply Support team.
  • Act as a manufacturing representative during device development stages (design control).
  • Act as a manufacturing representative in the packaging design process for the BTDM product portfolio.
  • Support Site Engeneering in defining assembly & packaging equipment design / qualification related to transfer / launch products.

Ideal Background

  • Education (minimum/desirable): PhD, Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology
  • Languages: Fluent in English and local language (German) an advantage

Relevant Experiences:

  • Minimum 5 years professional experience in Pharmaceutical Manufacturing (preferably assembly & packaging) / Manufacturing Science and Technology / technical Development in assembly & secondary packaging projects.
  • Thorough understanding of product processes and strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
  • Fundamental understanding of standard device/packaging analytical testing.
  • Expert in reviewing and writing technical reports.
  • Strong Project management skills.
  • Strong communication and intercultural skills with ability to work in a global matrix environment.
  • Knowledge in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications).
  • Knowledge of 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485, ISTA, ASTM and EMA medical device directive.

For further details please contact Beata Arciszewska:
email: beata.arciszewska@harveynash.com
tel: +41435088640

Harvey Nash AG
Beata Arciszewska
+41 44 296 8844