Description
invoX Belgium NV, the Respiratory Innovation Centre for invoX, is focused on the development of pharmaceutical products with superior delivery to the lung based upon differentiated technology in the form of our next generation Soft Mist Inhaler (SMI) device. Our proprietary, propellant-free, purely mechanical device delivers medication to the lungs more effectively than other types of inhalers and is poised to change the treatment paradigm in large markets including asthma and COPD.
To help continue our growth and success, we are looking for a Systems Engineer to join our Quality team in Diepenbeek (Belgium), reporting to the Head of Quality.
You will have responsibility for technical oversight of system and equipment validation activities related to development and manufacture of SMI, to ensure adherence to applicable regulatory GxP and Medical Device guidance.
As a key member of the development team, you’ll work within a complex matrix environment with multiple stakeholders and on cross-functional teams to advise on computer system, automated manufacturing and development laboratory equipment validation processes and global validation standards. Supporting technical R&D colleagues you’ll develop approaches to enable compliant development project delivery.
At invoX Belgium NV, development is achieved through an outsourcing model, so you’ll work with key development and manufacturing partners, ensuring compliant qualification and validation of our off-site assets. Additionally, you’ll be expected to travel to some of these key partners from time to time, working for periods on-site where required.
Key Responsibilities
External systems and equipment – Commercial drug product and medical device tooling, inspection and manufacturing lines:
- Quality oversight of external vendor validation activities (both remotely and on-site at external vendors globally).
- QA review of vendor validation documents and records as necessary (including protocols, reports, inspection and test methods – FAT/ SAT, IOPQ, MSA and GR&R).
- A Quality function signatory on internal/ external validation documents.
Internal systems and equipment – Development and bench equipment:
- Planning and implementing validation plans and test plans.
- Documenting, analyzing results, and reporting.
- Traceability of issues, support to resolution with the design teams.
- Training/ supervision.as necessary.
- Monitor compliance with safety and quality regulations.
- Supporting work in the following area:
- Maintenance of company certifications (ISO 13485).
- Developing procedures for use (SOP).
- Continuous Improvement (CI) of the company validation strategy, documents and systems of the QMS.
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