Lifescan Hiring for Senior Computer Software Validation(CSV) Engineer Job at Inverness, Scotland Full Time

Senior Computer Software Validation (CSV) Engineer
Remote based

Join us at LifeScan, maker of the iconic OneTouch® brand diabetes products to bring to life our mission to deliver personalized health & wellness experiences that engage people to live their best lives. LifeScan has had an unwavering commitment to improving the quality of life for people with diabetes by developing agile products defined by simplicity, accuracy, and trust to enable knowledge, wellness and health. We have virtual, dynamic and on-site employees in markets around the globe.
At LifeScan we believe our talented and passionate team is what makes us special. We inspire excellence and teamwork through our Shared Values of Care, Create, Connect and Compete.

We have a great opportunity for 2 CSV Engineers to join our high performing organisation due to expansion in the team. We are happy for you to be remote based but would love if you were conveniently located to visit our state-of-the-art manufacturing site in Inverness.

About the role:
These are critical roles within the team, providing leadership support for validation activities relating to Computer Systems. You will be key in ensuring that all compliance issues and requirements of LifeScan Validation policies and procedures are followed and maintained to a high standard. You will also help mentor and coach the team providing development support and ensuring ongoing development and Continuous Improvement for the team. It’s truly an amazing opportunity to join and support a highly professional team whilst offering a service which you can be proud.
Your typical day may include:

• Organise, lead validation working parties associated with computer systems and provide timely validation support to identified stakeholders.
• Carry out general investigative work using the QMS tool and implementing controls to mitigate the compliance risks from the investigation.
• Provide validation periodic review support to the business in all aspects of software development lifecycle processes.
• Provide audit support to the business in all aspects of software development lifecycle processes.
• Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations

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Requirements: Required Skills:

To be part of this high performing team you will have great attention to detail, alongside

• Degree qualified in a relevant discipline such as Electrical/ Electronic Engineering, Information Systems or Life Sciences with additional IT Knowledge
• Experience of working within a regulated industry carrying out verification and validation activities.
• In-depth knowledge of Medical Device or Pharma industry regulations; FDA, ISO, and industry best practices; GAMP/PICS
• Knowledge of bespoke software and/or hardware build, testing, documentation and deployment as part of software and/or system development lifecycle
• Knowledge of document and change management process
• Working knowledge of risk management tools e.g. FMEA, FTA or SRA
• Proactive problem resolution
• Self-directed; ability to work with minimal supervision as part of an interdisciplinary team
• Strong communication, both written and oral, with all levels of the business
• Proven mentoring/ coaching experience, either formally or informally achieved.

We pride ourselves in creating a fantastic team environment that allows everyone to grow and develop. Therefore, its important to us that you have:

• High Emotional Intelligence with an ability to manage large, multi-cultural teams
• Able to recognise and welcome diversity
• Flexibility and a solution oriented approach
• A spirit of continuous improvement

What you will gain from the role:

It is an exciting time to be joining the Lifescan team as we help people with diabetes. We believe that our people and excellent working relationships are at the heart of our success. Together, we create a good team spirit and friendly atmosphere to make it a great place to work, learn and develop.

By supporting and caring for our customers you will have the opportunity to gain that sense of achievement and moment of pride we all desire.

Of course, it goes without saying that we will support you to develop both personally and professionally whilst rewarding your performance.

If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for success then this would be the right role for you.

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Job Type: Full-time