Computer Systems Validation (CSV) Engineer
For our client, Johnson & Johnson Surgical Vision, we are looking for a Computer Systems Validation (CSV) Engineer.
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 a CSV Engineer, your main role is to provide technical expertise and guidance with regards to computerized software validation. You will be responsible for assessing the GxP impact of any new application and delivering compliance / validation plans and corresponding reports for the release of software to Production. In addition, you will review and approve associated documentation generated by the development engineers.
- Provide technical expertise and guidance with regards to the computerized system lifecycle and perform activities as needed;
- Provide independent Quality review and approval of CSV deliverables and ongoing GxP related change controls;
- Provide Quality and CSV oversight to ensure compliance with applicable regulatory requirements and Johnson & Johnson policies and procedures throughout the system life cycle;
- Ensure change control procedures are followed to maintain the system including its software in a validated state throughout the life cycle;
- Manage and execute Periodic Reviews per schedules;
- Implement controls to ensure data integrity and traceability of Quality records;
- Support process validations (IQ/OQ/PQ) and test method validation, where needed;
- Identify critical areas for improvement and prioritize and execute the initiatives resulting from this. As needed, perform or support nonconformance / CAPA root cause investigations, defining action plans and driving these to completion;
- Responsible for inspection readiness of the projects in scope of your work, and act as a Subject Matter Expert during internal and external audits (e.g. Notified Body or FDA).
Who we're looking for
To Successfully fulfill this position, we are looking for a candidate with a background in Mathematics, Engineering, Computer Science and at least 5 years of relevant working experience, preferably in automated processes within the pharmaceutical or medical device industry. You have experience in Software Development Life Cycle processes, including: Requirements Definition (functional/ compliance/ non-functional), Design specifications, programming techniques, Risk based Testing approaches, and Risks and corresponding controls (software/ procedural).
Other requirements for this positions are:
- Working knowledge of computerized systems validation, validation of products/equipment/processes, statistics, risk management, change control, and data integrity;
- Working knowledge of relevant Medical Device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11, ISO 13485, ISO 14971, IEC 82304, IEC 62304, FDA guidelines for Software Validation);
- Familiar with implementing or applying Agile development processes.
As a person, you are a self-starter, result driven, flexible, detail oriented, and able to function independently as well as in a team. You have good communication skills in English and preferably also in Dutch.
Johnson & Johnson Vision Care, onderdeel van Johnson & Johnson Medical B.V. zet zich in om het gezichtsvermogen in de wereld te transformeren. Wij streven naar de bewustwording van het belang van zicht en oogzorg en om de beste keuzes in visuscorrectie ter wereld te leveren.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Full time position for at least one year. |
Days of leave: 25 + 11
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.