of Job Role
Alvotech is looking to hire a Technical Lead to join the Technical Team in Combination Products & Devices department (CPD). The role is based in Stockholm, Sweden. This is an opportunity for an experienced mechanical engineer or similar, with a solid hands on experience from working with design/testing of devices for Needle Injection Systems. You will join a growing local team that will move into new facilities on the Karolinska Institutet Campus.
In this role you will support Alvotech’s ongoing product development programs by preparing and reviewing DHF documentation as technical SME and conducting technical investigations. You will also actively participate in shaping the collaboration both within CPD and across Alvotech functions. As our organization is in an exciting phase of growth and transformation, this role offers a blend of technical execution and strategic influence.
Scope and responsibilities:
Responsible for design verification preparation and testing by serving as the primary point of contact with external contract testing organizations.
Ownershipof thetemplatesforURS/DIR/DVand ensuring compliancewith technical standards and regulations.
Technical expertise in injection device functionality such as component interaction, assembly principles and critical drug-to-device interfaces.
Subject matter expertreviewerregardingdesign input/design output instagereviews followingAlvotech’s design controlprocess
Conductdesign impact assessmentsforproposeddesignprocess updatesandsupplier initiated changes
Provide technical support ininvestigations ofproduct qualitycomplaints
Cross-functional collaboration with Drug Product Developmenttoensure form, fit and function ofthepre-filled syringe in adrug-device combination
Support process improvements, including drafting or revising SOPs and contributing to departmental best practices.
Active involvement inthe Technical team’s ambition to
Establish in-housedevice testing capabilities(Stockholm).
Improve design transfer and control strategy planning
Develop methodology for device platform management, from development to product care.
Job requirements:
Bachelor or Master's degree inmechanical engineering orotherrelevant scientific or engineering field
Minimum of10years ofrelevantworkexperience,of which at least 5years arefrommedical devicesand/orcombinationproducts.
Technical analytical skillswitha capability tounderstand andevaluateengineering/test data
Strong understanding of design control frameworks, including DHF management, design verification/validation, risk management, and usability engineering.
Experience frommechanical testing andtest methoddevelopmentisadvantageous
Commitmentto contributing to Alvotech’s long term expansionand organisational development
What we offer:
Meaningful Work:Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people’s lives.
Global Growth:Join a fast-growing, international company with a diverse and inclusive culture.
Collaborative Environment:Work in a positive, flexible, and innovative setting that values teamwork and creativity.
Career Development:Benefit from support for personal growth, internal mobility, and ongoing training opportunities.
Cultural Exchange:Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays.
Well-being & Perks:Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee.
Community & Celebration:Participate in regular social events and celebrate team milestones together.
Our mission is to improve patient lives and the sustainability of the global healthcare ecosystem by broadening the availability and accessibility of biosimilars.
