Johnson & Johnson Careers

Senior CSV/Software Quality Engineer

Inverness, United Kingdom
Engineering (IT)


Job Description

Requisition ID: 1805659053W

Senior CSV/ Software Quality Engineer
Inverness, UK


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.

Qualifications
BE VITAL: 

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:  26th August 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.


Primary Location
United Kingdom-Scotland-Inverness
Organization
Lifescan Scotland Limited (form. Inverness Medical (7691)
Job Function
Engineering (IT)
Requisition ID
1805659053W