Senior Industrialisation Engineer; device assembly & packaging

Senior Industrialisation Engineer, (device assembly & packaging)

Department: Device Development

Employment Type: Permanent - Full Time

Location: invo

X Belgium N.V.

- Remote

Reporting To: Andrew Morris

The invo

X 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 invo

X’s respiratory combination products. As invo

X continues to grow, this is a compelling opportunity to work in a fast‑paced business. This role can be based in either Belgium, Germany, Portugal or the United Kingdom.

• Work collaboratively with the invo
  
  X RIC Device Development, Quality and Operations teams in the development of proof of principle, laboratory scale device assembly, packaging and associated technology for invo
  
  X’s combination products.
• Work collaboratively with the invo
  
  X RIC Device Development, Quality, Operations and CMC teams in the development of primary container/closure systems and secondary packaging for invo
  
  X’s combination products.
• Work collaboratively with the invo
  
  X 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 invo
  
  X 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 invo
  
  X 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 invo
  
  X 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 invo
  
  X Operations function.
• Support invo
  
  X 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.

• 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.

We get things done, we keep things simple and we are driven by the science. We are ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations and socialising, which make invo

X a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.