Are you a detailed-oriented Engineer with a passion for ensuring compliance in computer systems? Are you dreaming of a job with a real impact on patients ’lives?

Do you want to work for an innovative specialist spinal implant company and play a crucial role in ensuring efficiency of our processes?

If yes, come to join our Quality team!

As Computerized Systems Validation Engineer

Together we can shape the future of the healthcare.

As a CSV Engineer, you will be the primary point of contact for the business to define and scope CSV projects and testing strategy based on risk. You will ensure that all systems are fit for purpose, conform to relevant regulatory requirements as well as company specifications, requirements and standards.
Combining both risk and project management skills you will provide the validation strategy on upcoming projects and will have major focus on the life cycle management of all computerized systems.

Your main responsibilities will be:

Managing, co-ordinating, developing and executing the validation deliverables for new GxP computerized systems.
Ensuring that all computerized systems are operating as intended and meet regulatory & business requirements.
Performing cGMP compliance-based services specifically associated with Computerized Systems Validations & Data Integrity.
Supporting activities include but are not limited to: the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Testing (IQ/OQ/PQ), Data Migration, SOPs and Change controls.
Assessing the impact of changes proposed by IT department to computerized systems and the level of change required.
Providing validation strategy to the introduction of Computerized systems.
Improving the company policies and procedures
Ensuring that computerized systems are in full compliance with regulatory requirements.
Provide education and training on CSV related topics to areas of the business with specific requirements.
Supporting all hardware and software updates and revisions.
Supporting ongoing validation lifecycle management to provide confidence that validated systems and processes remain fit for use, including (but not limited to): monitoring; periodic re-evaluation; change management.
Representing the company to answer to Notify Body and regulatory authorities during audit as a CSV expert.
Regularly updating line management of the status of current CSV projects and escalating issues when appropriate.
Collaborating on a regular basis with the key stakeholders (Information Systems, Software assurance, users and suppliers) and management on all related matters.
Supporting and managing the audit programme for GxP software systems.

Your profile:

5-10 years’ experience as IT Engineer running project from requirements to delivery of final product and documentation included
Experience in Computer System Validation in Life Science industry, Pharmaceutical or Biotechnology is mandatory
Proven experience in the installation and qualification of Building Automation systems (Desigo, RMS Rotronic) is a strong plus
Familiar with Change Management tools and regulated document authoring
Awareness of 21-CFR Part 11, Eudralex, MHRA.
Able to work in English, french equivalent to mother tongue

We look forward to receiving your application at

https://spineart.bamboohr.com/careers/61?source=aWQ9MTE%3D