We have an opportunity for experienced engineering to oversee a project of technology transfer for packaging products in combination devices. This is 6 months project with possibility of extension. Major tasks: • Provides technical expertise from commercial point of view during device development stages and process commercilisation • Supports Launch Site Decisions at e.g. PAC 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, recourses) 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 readiness. • Performs Due Diligence initiatives and deals with negotiations for selected in-license and out-license projects. • Act as a manufacturing representative during device development stages (design control) • Act as a manufacturing representative in the packaging design process for the product portfolio • Support site engineering in defining assembly & packaging equipment design / qualification related to transfer / launch products Requirements: Education in Mechanical Engineering or Pharmaceutical Technology • Minimum 10 years experience in manufacturing / manufacturing science and technology / technical development/Quality in assembly & secondary packaging projects • Thorough understanding of product processes
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 skills • Knowledge regarding design control, documentation, risk management and processes such as DMR, DHF, pFMEA, Design Verification, and URS • 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485 knowledge, ISTA, ASTM, EMA medical device directive • Willingness to travel for short and long distance as well as time periods. • Flexibility in working hours due to globally located projects / manufacturing sites • Intercultural skills to work in a global environment.
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Michael Bailey International is acting as an Employment Business in relation to this vacancy.