Denna lista innehåller endast de länder där jobbannonser har publicerats på det valda språket (t.ex. i den franska versionen visas endast jobbannonser skrivna på franska, och i den engelska versionen endast de på engelska).
Make a Global Impact – Lead Validation Excellence in a Global Transfer Project. Are you a senior validation professional with deep GMP expertise and experience from regulated manufacturing? Do you want to play a key role in a global localization project within the medical device industry? We are now looking for a Senior Validation Engineer to join Nobel Biocare in Karlskoga. In this role, you will be part of the Process Engineering team, while operationally supporting a global implant localization project between Karlskoga, Sweden and Suzhou, China. You will act as a validation expert and bridge between Engineering and Quality, ensuring best-in-class qualification and validation practices across sites. Your work will be critical in securing compliance, quality, and successful product transfer.
Jobbansvar:
Act as a key global project member in the product localization project
Serve as the bridge between the Quality and Engineering organizations in Karlskoga and the corresponding teams in Suzhou
Guide the project in GMP best practices, pFMEA methodology, and validation strategy
Support the setup of the Site Validation Master Plan (SVMP) including attachments and validation structure
Drive and support qualification activities for facility utility systems, clean rooms, microbiology labs, equipment, software, and test methods (IQ/OQ/PQ)
Support the Engineering team in creating User Requirement Specifications, validation test plans, and validation reports
Ensure high quality and compliance of process and equipment documentation
Provide validation guidance to construction contractors related to qualification of utility systems
Krav:
A Bachelor’s or Master’s degree in Engineering or equivalent experience
At least 7 years of experience as a Validation or Process Engineer in a regulated industry
Solid experience within medical devices and ISO 13485 environments
Deep knowledge of GMP and qualification/validation of equipment and processes
Strong experience in process validation and product transfer
Experience working with pFMEA in a GMP-regulated environment
Strong skills in statistical data analysis and process setup
Experience working in cross-functional and international project teams
Fluency in Swedish and English, both spoken and written
Önskvärt:
Audit experience is considered an advantage
Knowledge of SAP or similar document management systems is a plus
Knowledge of the Chinese NMPA regulatory system is meritorious
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