Senior Validation Engineer

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.
Why This Role?

This is a unique opportunity to take a leading validation role in a high-impact global project. You will operate at the intersection of Engineering, Quality, and Project Management, contributing to the successful localization of implant manufacturing while ensuring the highest standards of compliance and patient safety.

As Senior Validation Engineer, you will:

• 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

Your Background

You are a senior validation professional with strong analytical capability and a structured way of working. You communicate with clarity and impact, and you are comfortable operating in a global, cross-functional environment. You combine deep regulatory knowledge with a pragmatic, solution-oriented mindset and the ability to drive results.

We believe you have:

• 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
• 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
• Fluency in Swedish and English, both spoken and written

Our top priority is to support our customers - those entrusted with patient care - and ensure that our development is driven by their needs, while continuing to grow with a customer-focused approach. This mindset also applies to colleagues and internal functions, who should be treated with the same dedicated customer focus.

With a learning and flexible approach and a focus on the future, we are equipped to create the next generation of groundbreaking ideas and products in the industry. We believe that innovation should be part of all functions and activities, and our employees are prepared to make a difference every day at work.

Diversity, inclusion, and equality are at the core of what makes our culture and teams so successful. We know that when our employees are allowed to be their true selves every day, we build stronger teams, foster more thoughtful dialogue, and have more reasons to celebrate success.

Supported by the Envista Business System, we are focused on developing world-class processes and people at all levels of the organization. Envista employees are motivated to do their best every day and work continuously to improve to meet set goals.

By providing our employees with the best training, opportunities for collaboration, and personal development, we ensure they are trusted and well-prepared to take responsibility for their commitments. Taking responsibility for both successes and failures, and quickly moving forward, ensures a trustworthy environment that contributes to success.

This is a project-based consultancy assignment of approximately 12 months. You will be employed as a consultant by OnePartnerGroup and assigned to work on-site or hybrid (as applicable) with Nobel Biocare. The assignment is time-limited, and the start date will be agreed upon.

The recruitment process is managed by OnePartnerGroup. Selection is ongoing, so we encourage you to submit your application as soon as possible.

As an initial step in the process, shortly after submitting your application you will receive an SMS and an email from our AI colleague Sara (sender: OnePartnerGroup/OPG) containing a link to a few screening questions. If your profile matches the requirements of the role, you will be invited to an interview with OnePartnerGroup.

If you have any questions regarding the assignment or the recruitment process, please contact the responsible recruitment consultant: Emma Landelius, emma.landelius@onepartnergroup.se, +46 76-8050058.

We look forward to receiving your application!