invoX Pharma

Senior Industrialisation Engineer, Device Assembly and Packaging

invoX Pharma

full-time

Posted on:

Origin:  • 🇧🇪 Belgium

Visit company website
✨ AI Apply
Apply

Job Level

Senior

Tech Stack

Assembly

About the role

  • The invoX Belgium NV, Respiratory Innovation Centre is focused on the development of pharmaceutical products.
  • To help continue our growth and success, we are looking for a Senior Industrialisation Engineer.  This position will be focused on the development and deployment of industrialised device assembly, packaging and associated process technology associated with invoX’s respiratory combination products.  As invoX continues to grow, this is a compelling opportunity to work in a fast-paced business.
  • Main Accountabilities
  • The Senior Industrialisation Engineer will work with both internal functions, primarily Device Development, Quality, Operations and CMC, external equipment vendors and contract manufacturing organisations.  It is expected this role will take responsibility for device, primary and secondary packaging manufacturing/assembly equipment, although an involvement in aseptic fill-finish equipment industrialisation may also be required.
  • Accountabilities and responsibilities include, but are not limited to:
  • Work collaboratively with the invoX RIC Device Development, Quality and Operations teams in the development of proof of principle, laboratory scale device assembly, packaging and associated technology for invoX’s combination products.
  • Work collaboratively with the invoX RIC Device Development, Quality, Operations and CMC teams in the development of primary container/closure systems and secondary packaging for invoX’s combination products.
  • Work collaboratively with the invoX RIC Device Development, Quality and Operations teams in the development of device component specifications, DFM, DFA, low-volume and high-volume manufacturing processes and associated design, verification and validation documentation.
  • Develop and maintain a knowledge of state-of-the-art assembly and packaging technology/equipment through external contacts and disseminate internally as appropriate.
  • Be an invoX subject matter expert on device assembly, packaging and associated technology.
  • Develop URS’s, RFP’s and RFQ’s for device assembly, packaging and associated equipment/contract manufacturing requirements as necessary.
  • Work with equipment vendors to develop and critique proposals, quotations, project plans, design documentation (such as FDS’s, HDS’s, SDS’s, FMEA’s) and validation documentation (such as IT/OT tests and protocols).
  • Manage collaboration with equipment vendors throughout concept development, design review, manufacture, documentation development, site acceptance, transfer into manufacturing, factory acceptance, site acceptance and validation activities in accordance with current good manufacturing practices.
  • Work with the invoX Device Development, Operations and Quality functions to select external CMO’s.
  • Manage collaboration with selected CMO’s throughout equipment development, design, build, FAT, technical transfer from vendor into the manufacturing site, installation, SAT, validation and readiness for commercial manufacture.
  • Support the invoX Quality function throughout equipment validation, readiness for manufacture and ongoing product quality oversight.
  • Drive and support continuous improvement/COG’s reduction activities in collaboration with CMO’s and the invoX Operations function.
  • Support invoX Device Development in the collation and management of the risk management and design control processes according to internal SOPs and regulatory guidance, including the establishment and maintenance of Design History Files and Technical Files.
  • Support Regulatory Affairs to prepare Medical Device/Combination Product preregistration documents and provide input to answer health authority questions.

Requirements

  • Desired
  • A Batchelor’s or higher degree in Technology or Engineering.
  • Considerable professional experience in a similar role within inhalation or parenteral device development/manufacturing industries and/or drug-device combination products.
  • Demonstrated success in the industrialisation and technical transfer of manufacturing/assembly processes.
  • Demonstrated track record of project and people management skills.
  • Experience of working effectively in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
  • Key Skills
  • Proactive, self-starter.
  • Strong project and people management skills.
  • Hands-on, problem-solver.
  • Out of the box thinker.
  • Able to multi-task, and to prioritize.
  • Flexible, with an ability to manage change.
  • Excellent communication skills, oral and written.
  • Fluent in English, oral and written.
  • Experience in an international environment.
  • Ability to travel internationally on a regular basis.