Medical Devices Packaging Expert

We are now recruiting for a consultant to manage Device & Secondary Packaging activities related to transfer and launch for assigned projects.

The successful candidate will lead project team for transfer and launch tasks related to device assembly and secondary packaging processes within the manufacturing area.

Main tasks:
Provides technical expertise from commercial point of view during device development stages and process commercialization.
Supports Launch Site Decisions at eg PAC (Post Approval Commitment) by providing analysis of technology, capacity and skills required, 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, Regulatory). Ensures PAI (Pre-Approval Inspection) readiness.
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 Engineering 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
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.

Please send your CV to beata Klecz

Michael Bailey International is acting as an Employment Business in relation to this vacancy.