(Validation Engineer, IQ, OQ and PQ protocols and reports)
For a leading Medical Device client, we are looking for a Validation Engineer. Responsible for developing, optimizing and implementing activities new and existing production (sub) processes and methods. Design, develop and realizing (concept) ophthalmic Medical Devices. In addition to designing, manufacturing and installing or having installed the necessary equipment and software on a continuous basis to achieve a reliable, robust and efficient production process.
- Developing new production processes and (test) methods, scaling them up and optimize.
- The design, manufacture and installation of necessary equipment
- Developing / adapting raw materials and / or the specifications for them
- Development of production materials
- Designing, developing and realizing (concept) ophthalmic Medical
- Devices using the Design Control process in New Product Introduction projects.
- Perform Product or Process Transfers to and from other locations.
- Participate in or lead project teams and other consultative bodies with regard to own task area.
- Drafting protocols, reports and performing validation tests
- Drafting and documenting product and process specifications and work schedules operating instructions
- Increasing and transferring product and process knowledge through training and Instructions
- Dutch & English is a must.
- Technically oriented training at a minimum HBO level, at preferably mechanical engineering, chemistry, automation, or electrical engineering
- Experience preferably in the pharmaceutical or medical device industry.
- Relevant GMP, QSR, MDD / EU MDR, ISO 13485, ISO 14971, ISO 11979
- Knowledge of Lean Six Sigma, Design Control, Product and process validations, Design For Manufacturability (DFM)
- Automation, Robotics, Industry 4.0
- Metrology and/or Sensoring
- Location: Groningen
- Full time on site
- 1 year contract (possibility of extension)
Interested? Send me your CV at email@example.com or call at +31 202044502.
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