Together we can make a difference
At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope just to name a few.
A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.
This position is responsible for IT computer systems validation with special focus on technology and applications development. This position will be responsible for interpreting technology projects in the context of CSV, defining validation approach based on the nature of the project, creating and owning the relevant documentation and activity in alignment with both local and global CSV governance in accordance with cGxP, CFR Parts 11, GAMP V and other applicable regulations or procedures.
- Provide technical expertise to define approaches and execution of system validation activities in accordance with cGxP, CFR Parts 11, GAMP V and other applicable regulations or procedures. Understand system architectures, development and dev-ops testing processes. Utilize this knowledge to define and control technology validation documentation.
- Develop and manage project technical documentation for SDLC requirements during computer system implementation projects including developing validation approach, validation planning, technical system process flows, technical installation, development and verification documentation (IQ/OQ/PQ).
- Collaborate with business teams and IT Applications Development SMEs to help write functional use cases, test cases, usability and testing documentation during required project phases.
- Understand and Utilize Agile methodologies for incremental and iterative applications development in the context of established computer systems validation processes.
- Initiate and enforce necessary improvements and corrections to established systems and processes.
- Work with applications development team to select methods and techniques for obtaining desirable solutions for each project and ensure compliance with regulations. Participate in relevant architecture, development code review meetings as necessary.
- Conduct technology compliance assessments and audits for systems and processes owned by US IT Applications Development.
- Collaborate with IT Validation Lead and Regional Quality Validation SMEs to align applications development validation plans to be in compliance with above referenced regulatory requirements and implement mitigation plans and change control as necessary
- Participate in internal and external vendor audits relating to computerized systems.
- Ability to work flexible hours and weekends to meet business/customer needs.
- Bachelor s Degree or equivalent in Computer Information Systems, Management Information Systems, Engineering or related fields.
- Training in Computer Systems Validation
- Competent in the use of MS-word, MS-excel, MS-powerpoint
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
We look forward to receiving your application. 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. We hope you will join us on our journey to become the world s most desired medtech company.
Associated topics: compliance, debug, h/w test, h/w test engineer, quality assurance, schema, test, test hardware, troubleshoot, verify