Device and Packaging Technical Manager / Combination Products (m/f) – Freelance – geschlossen

  • Position zu besetzen ab 6. August 2018
  • Permanent-ID OCR-FL-2018-1128
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 2x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Aufgaben

The Device Manager will have technical responsibility for the completion of combination product device activity across the supply base. They will work with sites and suppliers globally. The role will require flexibility to adapt to the resource needs of the business.

  • Input or manage all technical elements of Device combination product supply for the following lifecycle activities; investigation, change management, refurbishment and investment .
  • Support the organisation on Continuous Improvement and Business projects.
  • Support the Supply Chain on Lifecycle management, capacity ramp up, commercial supply and New product introduction
  • Manage their own time to resource projects in line with business needs.
  • To provide Technical competence and resource for Plastic Injection, Assembly, Device Testing, Secondary and tertiary packaging and other related processes.
  • Support cross functional Technical and Quality issues by working collaboratively with other support functions and the external supply chain.
  • Support & develop working relationship with suppliers globally.
  • Provide device related technical support to organisatuion governance where where required.
  • To champion and maintain common Ways of Working across the supply chain.
  • Lead and deliver a number of prioritised value adding projects as defined by Device Director and Supply Chain
  • Ensure all Device Technical activities conform to company and external regulatory compliance standards, thereby fostering a positive compliance culture. Support Device related activity at sites and be responsible for the integrity and quality of the data produced by the team and the technical content of reports written.
  • Develop and facilitate the introduction of standardised processes, agreed and introduced globally for the use by all parties.
  • Understand Health, Safety and Environmental regulations and promote a positive safety culture.
  • Provide Technical support to organisation governance for Business Improvement projects and Risk Management activities. Use Lean Sigma techniques and innovations to provide business benefits to suppliers and organisation.
  • Support and lead when required investigations to resolve device customer complaints & complex technical issues.
  • Manage and co-ordinate activity across device suppliers
  • Maintain Technical link across the supply chain and develop collaborative working and knowledge sharing
  • Support technical decisions in line with business needs and produce technical justifications for those decisions. Ensure that stakeholders and customers have brought into those decisions.
  • Provide Device Director with support on review of viability of device and process changes and associated manufacturing robustness improvements
  • Support the Technology Transfer of New Device Product Introductions from R & D into Manufacturing.
  • Makes recommendations based on performance trend analysis on site and supplier based data as required.
  • Oversee line trials required for the introduction of new supply base capital or trials required for product investigation etc.
  • Makes recommendations based on performance trend analysis on site and supplier based data as required.
  • Suppport business investments for capacity installation and asset life cycle management ensuring organisation attains best value for money.
  • Technical support for New Product Introduction launches. Scale-up & Industrialisation of device supplier manufacturing capability by participating in activities with external suppliers.
  • Autonomously manages major projects relevant to the devcie in an efficient prioritised manner.
  • Manage device related activity in respect of CAPA’s, specification management, Site/ Supplier change control.
  • Organise site based testing with Site Device Technologists as required to support business.
  • Acts as a mentor to Device Technologists in the supply baseAnforderungen
    • Experience in manufacturing of medical devices or similar related industry > 5 yrs.
    • Extensive experience of medical device manufacture (polymer processing, high speed assembly etc). > 5 yrs.
    • Good appreciation of pharmaceutical GMP, pre-approval inspection readiness and Company regulatory requirements > 5 yrs.
    • Good understanding to enable management of metrology & plastics testing techniques & procedures and GSK Specification & Drawing systems > 5 yrs.
    • In depth knowledge of plastic injection moulding and assembly > 5 yrs.
    • Mechanical Engineering qualifications or equivalent discipline > 5 yrs.
    • Understanding of the pharmaceutical development activities and processes adopted by R & D relating to product development and Technology Transfer. > 5 yrs.
    • Understanding of the pharmaceutical regulatory environment plus the specific additional legislation needs for medical devices e.g. EC ‚CE‘ marking, FDA Medical Device guidance > 5 yrs.
    • English: business fluent; German: nice to have

    Zusätzliche Informationen

    Standort: Hamburg

    Projektbeginn: August 2018

    Projektlaufzeit: 31.12.2018 (100 Tage)
    mit Verlängerungsoption um 6 Monate

    Verfügbarkeit: Vollzeit

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