Computerized System Validation Lead at Elos Medtech

Elos Medtech; Dubai; Remote; AED 200,000 - 300,000; Full time

Job summary

Elos Medtech seeks a Computerized System Validation Lead to spearhead validation of critical IT systems in a dynamic medtech environment. This full-time role involves ensuring compliance with stringent regulatory standards while contributing to a data-driven transformation within the organization. The ideal candidate will possess extensive experience in software validation, complemented by a solid background in the Life Sciences domain.

Benefits

Attractive salary based on qualifications

Flexibility in work environment

Opportunities for growth within the company

Qualifications

• 5+ years experience in Computer Software Validation.
• Knowledge of FDA Standard for electronic signatures.
• Experience working in Life Science industry.

Responsibilities

• Lead and execute validation activities in global projects.
• Conduct impact and risk assessments.
• Evaluate new releases for re-validation.

Skills

Communication

Problem-Solving

Decision-Making

Education

Bachelor’s degree in engineering

Bachelor’s degree in computer science

Tools

MES

ERP

iPAAS

Job description

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Job Category : IT

Job Type : Full Time

Job Location : Global

Are you ready to lead the validation of critical global IT systems in a growing and digitalizing medtech company? We are seeking an experienced Computerized System Validation Lead to join Elos Global IT team to lead and execute validation activities for our digitalization projects and implemented global applications.

Elos Medtech is a company in growth and in a transition phase. We are on the path of becoming a data-driven and digitalized Medtech company, focusing on building an eco-system of best of breed applications to support our business needs.

We prioritize digitalization and here you will have a say in our direction and methods. Engage in interesting IT transformation projects, with a focus on Cloud and Integration Platform as a Service (iPAAS). Join us for a fulfilling role where you can contribute to our digitalization journey and be part of a dynamic team!

The role

As we evolve, it becomes increasingly crucial to maintain our digital ecosystem in a validated state. This is why we are seeking a Computerized System Validation Lead who can ensure that our systems and processes adhere to stringent regulatory standards and software validation requirements according to ISO13485. By joining our team, you will play a pivotal role in safeguarding the integrity of our operations.

Responsibilities

• Lead and execute validation activities in global projects

Impact assessments

Risk assessments (regulatory and functional)

Documentation

• Evaluating if new releases require re-validation

Requirements

• Bachelor’s degree in engineering, computer science or a related field.
• 5+ years of experience of Computer Software Validation.
• Knowledge about MES, ERP, iPAAS.
• Experience from working in Life Science industry.
• Detailed knowledge of FDA Standard for electronic signatures and electronic records (21 CFR Part 11) as well as the GAMP 5 approach for Software validations.
• Fluent in English, both verbal and written.
• Excellent communication, problem-solving, and decision-making skills.
• Bonus :

Experience with Cloud System Validation

In this role, occasional travel is required to support various projects and initiatives.

If you have a passion for validation and find yourself in the above criterias, we want to hear from you! This is an exciting opportunity to lead the validation of critical global systems that will help us to drive our business forward and achieve our digitalization strategy.

Why Join Us?

• The opportunity to contribute to an important industry and make a difference in people’s health.
• You will get an attractive job in an international company that has a strong focus on digitalization and where quality and high precision is in our DNA.
• Become part of a flat organization with an informal tone, humor, and positive attitude as an important part of everyday life.
• Focus on employee well-being with flexibility, joy, and development in the job.
• Be part of a company that values diversity, equity, and inclusion.
• Opportunities for growth – both in your role and within the group.
• Elos Medtech provide a market-competitive salary based on qualifications and experiences.

Ready to make a meaningful impact? Apply for the position immediately, as we keep the interviews ongoing.

Elos Medtech is a multinational company with a presence in Sweden, Denmark, the US, China, Germany, and Switzerland. The selected candidate for this position should be based in any of these countries.

Start Date : As per agreement

Application : Apply as soon as possible – we interview on a rolling basis.

Questions about the position? Contact : Johanna Boström, Digital Transformation Director [e-mail]

Questions about the recruitment process? Contact : Lina Rydberg, Recruitment Manager [e-mail]

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Information Technology

Medical Equipment Manufacturing

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