Make a Global Impact – Develop the Future of Medical Device Manufacturing
Are you an experienced validation engineer who thrives in a high-tech, regulated environment? Do you want to be part of a team that transforms how medical devices are manufactured through automation, innovation, and smart engineering?
We’re looking for a Senior Validation Engineer to join Nobel Biocare in Karlskoga – a key site within our global manufacturing network.
In this role, y... Visa mer
Make a Global Impact – Develop the Future of Medical Device Manufacturing
Are you an experienced validation engineer who thrives in a high-tech, regulated environment? Do you want to be part of a team that transforms how medical devices are manufactured through automation, innovation, and smart engineering?
We’re looking for a Senior Validation Engineer to join Nobel Biocare in Karlskoga – a key site within our global manufacturing network.
In this role, you will plan, execute, and document validation activities to ensure that production equipment and processes comply with regulatory and quality standards. Your work will be essential in maintaining robust manufacturing processes and securing the highest levels of product quality and patient safety.
About the role
As a Validation Engineer, you will play a key role in ensuring that our processes, equipment, and systems meet regulatory requirements and internal quality standards. You will work closely with production, quality, and development teams to drive validation activities from planning to execution and documentation. Additionally, you will be responsible for managing the risk management process in compliance with applicable standards.
Your responsibilities
Plan, execute, and document process validation and equipment validation (IQ/OQ/PQ).
Develop and maintain validation protocols and reports in compliance with ISO 13485 and GMP.
Lead and maintain the validation and risk management process.
Participate in risk assessments and change control processes.
Support internal and external audits.
Collaborate with cross-functional teams to implement improvements and ensure compliance.
We are looking for someone who has
Feels confident taking on significant responsibility, as you will have an important role within the team.
Is humble, positive, and a team player who enjoys sharing knowledge and learning from others.
Has a degree in engineering, chemistry, biotechnology, or equivalent.
Has several years of experience in validation and qualification work within a GMP-regulated industry, combined with relevant education.
Has experience in process validation within medical devices, pharmaceuticals, or other regulated environments.
Possesses solid knowledge of ISO 13485, GMP
Has previously worked in industries with high demands on traceability, quality, and control.
Experience with cleanrooms and cleanliness is an advantage, as well as previous work with ISO 13485.
Quickly identifies critical steps, has strong analytical skills, and is used to meeting deadlines.
Is comfortable working with people from different areas of expertise and speaking in front of a group.
The role involves various points of contact both nationally and internationally, which requires excellent proficiency in Swedish and English, both spoken and written.
Experience with SAP is a plus.
We offer
A dynamic work environment with high technical expertise.
The opportunity to influence and develop processes that make a real difference in patients’ quality of life.
Competitive benefits and career development opportunities.
Our Core Values Defines Us
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.
Other information
This recruitment is conducted in collaboration with OnePartnerGroup, but employment and contract will be signed with Nobel Biocare. Selection is ongoing, so please submit your application as soon as possible.
The start date will be determined by agreement.
If you have any questions, feel free to contact the recruitment consultant:Emma Landelius,
[email protected], +46 76-8050058.
As a first 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) with a link to answer a few selection questions.
We look forward to receiving your application!
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