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Computerised Systems Validation (CSV) Engineer

Vacaturenummer: A2100206
Johnson & Johnson Surgical Vision - Groningen (Nederland)

For our client, Johnson & Johnson Surgical Vision, we are looking for a Computerised Systems Validation (CSV) Engineer.

Keywords

  • CSV
  • Software Development Life Cycle (SDLC)
  • Medical Devices/Pharma
  • Medical Device regulations
  • Agile


Profile
A project has started to further develop intraocular lenses (IOL) manufacturing technology with a high degree of automation. Therefore, the Quality Department is looking for a Computerised Systems Validation (CSV) Engineer
As a CSV Engineer within the Quality Department, your main role is to provide technical expertise and guidance with regards to computerised 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 equipment/software to Production. In addition, you will review and approve associated documentation generated by the development engineers.

Main tasks:
  • Provide technical expertise and guidance with regards to the computerised 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 prioritise and execute the initiatives resulting from this. As needed, perform or support non-conformance / 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
The ideal candidate has at least a relevant B.Sc. degree with 5 years of relevant work experience, preferably in automated processes within the pharmaceutical or medical device industry. Additionally, you should have the following:
  • Knowledge of and experience in Software Development Life Cycle (SDLC) processes, including: Requirements Definition (functional/ compliance/ non-functional), Design specifications, programming techniques, Risk based Testing approaches, and Risks and corresponding controls (software/ procedural);
  • Working knowledge of computerised 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;
  • Self-starter, results driven, flexible, detail oriented, and able to function independently as well as in a team;
  • Good communication skills, including excellent command of the English language and preferably the Dutch language.


Company profile
J&J Surgical Vision in Groningen is the Centre 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.


Department
Quality Department

Additional vacancy information
Reference:A2100206
Contract:Temporary contract with CLS Services
Education:HBO/BSc. WO/MSc.
Employment terms:Salary: >3500
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Project for at least 1 year
This position requires someone who will work both off- and on-site.
Publication date:30-9-2021
Location:View location with Google Maps
Contactperson:Aniek Vugts
+31 (0)88 22 77 555

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