Looking for a new challenge? You want to be part of an international company that brings together the best experts in the field of Life Science?
For one of our clients of the pharma sector we are searching for a Biotech Technical Specialist.
Interested? Then be sure to read on!
As a Technical Steward Biotechnology (equipment & products), you provide technical direction and support for assigned combination products throughout the product life cycle from late stage development, through technical transfer, scale up, life cycle maintenance and removal from the market.
Your responsibilities include, but are not limited to:
- Support the Manufacturing sites and Manufacturing Science & Technology Global organization for the device and combination product activities, including design, leading and managing assigned projects and business operations during late stage development, handover from development, product lifecycle management, up to the retirement of the product. This includes the management of changes, deviations and suppliers as well as supporting all post market activities according to regulations.
- Enable knowledge management for processes and products within department and across Aseptics Platform sites / functions.
- Provide technical leadership across sites for assigned Medical Device & Biologicals and validation across late stages of development through product end of life.
- Support operational excellence strategies to improve combination product quality, reliability, sustainability and reduce risk.
- Provide technical expertise supporting quality and compliance on issues related to or regarding Quality
- Support post market activities like post market surveillance, vigilance, annual review, etc.
- Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge and to ensure implementation of efficient and robust processes for the manufacture, packaging and/or analysis of Medical Devices/Combination Products (e.g. as manufacturing representative for Devices and Combination Products development projects).
- Responsible for drug/device combination stewardship including maintenance of technical documentation files such as Design History Files, human factors files, risk management file, change control and support of regulatory filings and combination products pre-launch and post-launch.
- Ensure the compliance with applicable GMP, regulatory, ISO and other requirements for combination products throughout life cycle.
- Participate in the definition and selection of medical device equipment, through providing input to User Requirements.
What you’ll bring to the role:
• Master degree in scientific field (Medical Device Technology, Pharmacist, bioengineering or equivalent engineering).
• Fluent in English and willing to learn Dutch.
• Minimum 5 years’ experience in GMP manufacturing relevant to the specialist area of expertise. Good knowledge of compliance and/or GMP shop floor experience.
• Proven process understanding (Medical devices, GMP, Regulatory aspects).
• Sound experience of data handling and applied statistics.
Then contact :
Maraim Sbihi (Senior Talent Acquisition Expert)