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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?

1. Maintain the validated state by supporting change control processes and validated system reviews. Supporting IT Validation Electronic Documentation Repository.
2. Coordinate 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, advising IT and the user community on compliance.
3. Work with internal and external auditors to defend IT validation components of regulatory and compliance audits.
4. Maintain current knowledge of pertinent regulations by attending seminars, subscribing to compliance publications, and collaborating with global staff members in IT, Regulatory, and Quality.
5. Support and adhere to all IT policies, procedures and standards, including IT Guiding Principles, Project Management, Change Management, and Internal and External Compliance.

What will you need to be successful?

1. A bachelor’s degree in Computer Science, Engineering, or a related field, or equivalent training and experience.
2. Fluency in English.
3. At least 2 years of experience in GxP Computer System Software Validation, with additional experience in IT infrastructure and cloud computing in healthcare being a plus.
4. Knowledge of Agile validation processes, GAMP 5 framework, and certifications in quality systems, CSV, or CSA are beneficial.
5. Strong decision-making skills, with the ability to analyze issues, develop solutions, and escalate when necessary.
6. A collaborative mindset, building strong working relationships and adapting communication styles to gain commitment from stakeholders.
7. A 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.

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.

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