CSV Engineer

Location Groningen
Discipline: Medical Device
Contact name: Aimee Brenner

Contact email: a.brenner@panda-int.com
Job ref: 14388
Published: 23 days ago

I am urgently recruiting for a motivated CSV Engineer to join the Quality Department of a renowned Medical Device Company in Groningen.

The site is responsible for the design and manufacture of vision care products. You will be part of a new exciting project to further develop IOL manufacturing technology with a high degree of automation.
Responsibilities:

  • Provide technical expertise and guidance with regards to the computerized system lifecycle
  • 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
  • Ensure change control procedures are followed to maintain the system
  • 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
  • As needed, perform or support nonconformance / CAPA root cause investigations, defining action plans
  • Act as a Subject Matter Expert during internal and external audits (e.g. Notified Body or FDA)
Profile
  • At least 5 years of relevant work experience, preferably in automated processes within the pharmaceutical or medical device industry.
  • At minimum a relevant Bachelor degree.
  • Knowledge of and 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).
  • 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.
  • Excellent command of the English and preferably Dutch

Practicalities

  • Duration: 1 year contract
  • Start date: 1 Nov 2021 or ASAP
  • Able to work both on and off site
  • Location: Groningen

Interested?

Please apply with your CV. For further information, please contact Aimee Brenner at +31 (0)20 20 44 502 or by email at a.brenner@panda-int.com

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