Johnson & Johnson Careers
Computer System Validation QA Engineer
Requisition ID: 1905716107W
J&J Surgical Vision in Groningen is the Center of Excellence for the development of innovative solutions for the surgical ophthalmic market, mainly intraocular lenses (IOLs). The site is responsible for the design and manufacture of these products. A project has started to further develop IOL manufacturing technology with a high degree of automation. Therefore, the Quality Department is looking for a
Computerized Systems Validation (CSV) Engineer
As CSV Engineer within the Quality Department, your main role is to provide technical expertise and guidance with regards to the computerized software being qualified. In addition, you review and approve the documentation that is being generated by the development engineers.
For the first year of the project, you are willing to travel for several days to Eindhoven when needed.
- Provide technical expertise and guidance with regards to the computerized software being qualified, perform activities as needed;
- Provide independent quality review and approval of validation deliverables and ongoing GxP related change controls;
- Providing Quality and Computer System Validation oversight to ensure compliance with regulatory requirements (for example, GxP, Part 11, and Annex 11) and Johnson & Johnson policies and procedures throughout the application life cycle;
- Ensuring change control procedures are followed to maintain the application in a validated state throughout the life cycle.
- At least 5 years of relevant work experience, preferably in the pharmaceutical or medical device industry;
- At minimum a relevant Bachelor degree;
- Working knowledge of computerized systems validation, validation of products/equipment/ processes, statistics, data integrity;
- Self-starter, result driven, flexible and accurate, able to function independently as well as in a team;
- Good communicative skills, excellent command of the English language and preferably the Dutch language.
AMO Groningen BV (8358)