Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

At Smith+Nephew we are looking for: IT Validation Specialist

The IT Validation Specialist works in the Information Technology Group and reports to the Manager IT Compliance/Validation.  The main role of the IT Validation Specialist is to ensure that IT computer system validations are delivered in compliance with all applicable laws and regulations within the framework of the IT Solution Delivery Methodology and maintain the validated state of computer systems by being integral in processes such as change management and validated system reviews.

What will you be doing?

Maintain the validated state by supporting change control processes and validated system reviews. Supporting IT Validation Electronic Documentation RepositoryCoordinate computer system validation efforts within the Quality System Regulation (21 CFR Part 820), Electronic Records; Electronic Signatures (21 CFR Part 11), 21 CFR Part 210/211 and local regulations. This role includes advising IT and the user community what falls under these regulations and helping to coordinate efforts toward compliance with them.Work with internal and external auditors to defend IT validation components of regulatory and compliance audits. Maintain current knowledge of pertinent regulations.  This is accomplished by attending seminars, subscribing to compliance publications, and working with global staff members in IT, Regulatory, and Quality to understand specific site requirements.Support and adhere to all IT policies, procedures and standards, including but not limited to, IT Guiding Principles, Project Management, Change Management, Internal and External Compliance such as Health & Safety, Quality, Regulatory and Finance, and support of Internal and External Audits

What will you need to be successful?

A bachelor’s degree in Computer Science, Engineering, or a related field, or equivalent training and experienceFluency in EnglishAt least 2 years of experience in GxP Computer System Software Validation, with additional experience in IT infrastructure and cloud computing in healthcare being a plusKnowledge of Agile validation processes, GAMP 5 framework, and certifications in quality systems, CSV, or CSA are beneficialStrong decision-making skills, with the ability to analyze issues, develop solutions, and escalate when necessaryA collaborative mindset, building strong working relationships and adapting communication styles to gain commitment from stakeholdersA proactive and improvement-focused approach, challenging the status quo and driving innovation to meet IT goals

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website

Your Future: annual bonus, life insurance, company stock saving plan

Work/Life Balance: paid volunteering hours, flexible approach

Your Wellbeing: private health care with dental care package, multisport card/my benefit platform

Flexibility: possibility of working in hybrid model

Training: Hands-On, Team-Customized, subsidies for language classes, certifications and postgraduate studies

Extra Perks: referral bonus, recognition program, mentoring program

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