At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

Are you looking for an inspiring career? You just found it.

We are now recruiting a Senior IT Computer System Validation specialist to our Compliance and Quality Systems team in Group IT.

Group IT is part of the Operational Services Organization and our vision is to shape Getinge`s Digital Future Through Adaptive & Innovative Services by providing both state-of-the-art and cost efficient IT solutions. By close collaboration with our business stakeholders we ensure that we support our common business goals while still considering our internal and external compliance and security requirements.

Compliance and Quality Systems unit is part of the Group IT and has the objective to implement and operate IT Quality Management System and to ensure that all IT processes, procedures and systems comply with the applicable quality and compliance regulations.

Your Responsibilities:

Depending on your qualification and preferences you will be responsible for following:

• Ensure compliance with Quality & Compliance regulations and Quality standards applicable to Group IT according to the Quality Management System:
  • Stay updated with relevant regulations and standards in the IT industry.
  • Monitor and assess the compliance status of computerized systems.
  • Identify and implement necessary measures to ensure compliance
• Define validation approaches for computerized systems owned by Group IT (e.g., SAP, TrackWise, M-Files, etc.) in alignment with the CSV framework and other applicable regulations or procedures:
  • Evaluate the criticality and complexity of systems to determine appropriate validation strategies.
  • Develop and maintain CSV documentation, including validation plans, protocols, reports, and traceability matrices.
  • Ensure proper documentation of validation activities, deviations, and change control processes.
  • Collaborate with system owners, stakeholders, and validation teams to ensure effective validation processes.
• Manage, lead, and/or support CSV projects together with internal employees and external consultants as needed:
  • Take responsibility for overseeing CSV projects, ensuring timely and successful completion.
  • Coordinate project activities, allocate resources, and track progress.
  • Collaborate with internal teams and external consultants to ensure project objectives are met.
• Manage, lead, and/or support the qualification of software and infrastructure components supporting regulated systems:
  • Develop qualification strategies for software and infrastructure components.
  • Execute qualification activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
  • Collaborate with relevant teams to ensure effective qualification processes.
• Provide consultancy regarding CSV compliance within the Group IT and other stakeholders as needed:
  • Act as a subject matter expert on CSV compliance and regulations.
  • Provide guidance and support to Group IT teams and stakeholders on CSV-related matters.
  • Conduct training sessions or workshops to promote awareness and understanding of CSV compliance
• Support the implementation and maintenance of (IT) Quality Management Systems:
  • Assist in the development and implementation of Quality Management Systems.
  • Participate in process improvement initiatives to enhance the effectiveness of Quality Management Systems.
  • Conduct internal audits and assessments to ensure compliance with established quality standards.
• Support and participate in Group IT Quality-related audits (regulatory audits):
  • Collaborate with audit teams to prepare for and participate in quality-related audits.
  • Assist in gathering and organizing documentation and evidence for audit purposes.
  • Address audit findings and implement corrective actions as required.

Your Experiences:

• Master's or Bachelor's degree in IT, Quality, Engineering, or a related field of study.
• A minimum of 2 years (senior 5) of experience in the field of Computer Systems Validation (CSV) and/or Quality Management Systems.
• Successful management of at least two projects (implementations) in a Validation or Quality-related role.
• Experience with validation of cloud-based applications and/or infrastructure.
• Familiarity with quality tools such as Document Management Systems, data analysis, and statistics.
• Good knowledge of applicable regulations and standards related to computer system validation: ISO 13485, FDA's QSR, GAMP5, ITIL.
• Specific to the role of SAP Validation Specialist:
  • Very good knowledge of SAP systems and applications, including Solution Manager.
  • Successful management of at least two SAP implementation projects.

Your Skills:

• Strong project management skills to plan, execute, and deliver validation projects within defined timelines and budgets.
• Excellent written and spoken English, German language skills are plus.
• Effective communication, intercultural, and networking skills with the ability to work independently in a well-structured and systematic manner.
• Proactive and structured way of working, with a solution-oriented mindset and the ability to work collaboratively in a team.
• Flexibility and adaptability in a fast-paced environment.
• Proficiency in using quality tools, software, and technologies relevant to computer system validation and quality management.
• Strong analytical and problem-solving skills to identify and address validation gaps and deviations.

The position will be located in Europe, ideally at one of our sites in Sweden alt. in Copenhagen (Denmark) or Rastatt (Germany). Remote working is possible and occasional travel is expected to a a maximum of 10%.

If you have any questions, please contact Hiring Manager, Dario Budija, dario.budija@getinge.com .

About us

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart.

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company.