Johnson & Johnson Careers
Senior CSV/Software Quality Engineer
Requisition ID: 1805659053W
Senior CSV/ Software Quality Engineer
LifeScan Scotland Limited, a medical device company established in Inverness in 1995 to design and manufacture glucose test strips, and design electronic meters for the global diabetes market.
The team at LifeScan Scotland designs all the products in the OneTouch® Brand of blood glucose monitoring systems (meters, test strips, control solutions, lancing devices and diabetes management software). The OneTouch® brand has two product families – Ultra® products, made from carbon technology, and Verio® products, made form precious metals technology. LifeScan Scotland is the primary OneTouch® test strip manufacturer for the global market.
We have an exciting opportunity for a Senior CSV/ Software Quality Engineer to join our team in Inverness. This is a senior role within the team, providing leadership support for validation activities relating to Computer Systems. This role is key in ensuring that all compliance issues and requirements of LifeScan Validation policies and procedures are followed and maintained to a high standard. The Senior CSV/ Software Quality Engineer will also help mentor and coach the team providing development support and ensuring ongoing development and Continuous Improvement for the team.
What you’re great at:
• Awareness of Computer Systems regulations
• Computer Validation
• Ability to work independently as well as part of an interdisciplinary team
• Motivational and Influencing approach with strong communication skills
• Bespoke software and/or hardware build, testing, documentation and deployment
As a Senior CSV/ Software Quality Engineer, 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
What you’ll own and how you’ll grow:
You will own the computerized validation process, including periodic review attributes. You will also own the continuous Improvement elements; making improvements to the established process whilst maintaining regulatory requirements are maintained.
This is an exciting time to join our expanding team, we are moving forward with new structure which will allow you the opportunity to shape the team and the way we work in the future.
We will support you to develop both technically and personally. You will also be rewarded by knowing you are helping patients across the world.
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.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At LifeScan our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each:
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
Closing Date: 30th June 2018
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 caring and success, then we invite you to join the LifeScan Talent Community by visiting www.careers.jnj.com
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by LifeScan. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Lifescan Scotland Limited (form. Inverness Medical (7691)