CSV/Software Quality Engineer

Job description

CSV/ Software Quality Engineer, LifeScan Scotland Ltd
Inverness, United Kingdom

LifeScan is a Johnson & Johnson company. LifeScan Scotland was created in 2001 when Johnson & Johnson acquired the UK assets of Inverness Medical Ltd, 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.

With a focus on future development, LifeScan is committed to “creating a world without limits for people with diabetes.” Around 1,000 people are employed at the Inverness site, which is regarded as Johnson & Johnson's centre of excellence for diabetes and self-monitoring of blood glucose (SMBG).

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.

To find out more about LifeScan Scotland, please visit: www.lifescan-scotland.co.uk.

To find out more about careers at LifeScan Scotland, please visit: www.lifescan-scotland.co.uk/working-for-us.

We have an exciting opportunity for a CSV/ Software Quality Engineer here in Inverness. You will provide support for the validation activities associated with computer systems, process and facilities ensuring that all compliance issues and requirements of J & J validation policies and procedures are addressed and maintained.

What you're great at:

Providing information and awareness on current computer systems regulations that must be adhered to, to achieve and maintain compliance and support business computer validation and/or validation needs.

Working with minimal supervision as part of an interdisciplinary team, with the ability to recognise and nurture junior validation engineers.
Motivating and influencing validation working parties through effective communication to ensure validation is carried out in a compliant and timely manner.

Bespoke software and/or hardware build, testing, documentation and deployment as part of system development lifecycle with a risk based approach mind set.

As a 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 system or software development lifecycle processes.

Provide audit support to the business in all aspects of system or software development lifecycle processes.

What you'll own and how you'll grow:

The right candidate will be the computer systems and/or process validation process subject matter expert for Scotland and affiliated partners, whilst ensuring the requirements of regulatory bodies and J & J policies, and procedures are maintained.

Desired profile

BE VITAL:

To be part of this critical high performing team you will be degree qualified or equivalent in a relevant discipline (e.g. Electrical/Electronic Engineering, Information Systems or Life Sciences with additional IT knowledge) teamed with in depth knowledge of medical device or pharmaceutical industry regulations (e.g. FDA, ISO or applicable European regulations and industry best practices such as GAMP/PICS). Together with:

• Minimum of 3 years experience working in a regulated industry carrying out verification & validation activities
• 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

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 Johnson & Johnson 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

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 Johnson & Johnson 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 Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.