Stockholm, Sweden · Hybrid
Overview 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 exper…
Skills: Mechanical engineering, Needle injection systems, Design verification, DHF management, Design control
Bengaluru, Karnataka, India · Remote Solely
Job Title: Director, Statistical and Data Management Programming About the Department/Company Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of hig…
Skills: Statistical Programming, SAS, Biometrics, Clinical Trials, Data Management
Reykjavik, Iceland · On-site
Gakktu til liðs við framleiðsluteymi hjá Alvotech í Reykjavík! Alvotech starfar í reglubundnu umhverfi þar sem nákvæmni og samviskusemi skipta sköpum. Við leitum að einstaklingum með jákvætt hugarfar, góða aðlögunarhæfni…
Skills: Aseptic processing, Drug product manufacturing, cGMP, Cleanroom operations, SOP management
Reykjavik, Iceland · On-site
Alvotech is a fully integrated specialty biopharmaceutical company dedicated exclusively to the development and manufacturing of high-quality biosimilar medicines. Our mission is to improve lives worldwide by increasing …
Skills: EHS programs, Risk assessment, Regulatory compliance, Biotechnology manufacturing, Internal auditing
India · Remote OK
Overview of role: We are seeking a Master Data Lead to drive the integrity, accuracy, consistency, and governance of critical business data across SAP and associated systems. This role plays a key part in ensuring high-q…
Skills: Master Data Governance, Data Quality Management, SAP, Financial Reporting, Procurement Processes
Reykjavik, Iceland · On-site
QC Bioassay Principal Scientist We are searching for a motivated and detail oriented QC Bioassay Principal Scientist to support quality control testing activities for biosimilars. This role is responsible for executing a…
Skills: Bioassay, Cell-based potency assays, ELISA, Binding assays, GMP standards
Reykjavik, Iceland · On-site
QC rannsóknarstofutæknir / QC Laboratory Technician Við leitum að nákvæmum og áreiðanlegum QC rannsóknarstofutækni með sterka áherslu á gæði og öryggi til að styðja við daglegan rekstur gæðastýringarrannsóknarstofu. Star…
Skills: Quality Control, GMP compliance, GLP compliance, Laboratory maintenance, Reagent preparation
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The Testing Lead will oversee design verification and testing, serving as the primary contact for external testing organizations. They will also act as a technical SME for DHF documentation and contribute to the establishment of in-house device testing capabilities.
Candidates must hold a Bachelor or Master's degree in mechanical engineering or a related field. A minimum of 10 years of relevant experience is required, with at least 5 years specifically in medical devices or combination products.
Overview 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.
Ownership of the templates for URS/DIR/DV and ensuring compliance with technical standards and regulations.
Technical expertise in injection device functionality such as component interaction, assembly principles and critical drug-to-device interfaces.
Subject matter expert reviewer regarding design input/design output in stage reviews following Alvotech’s design control process.
Conduct design impact assessments for proposed design/process updates and supplier initiated changes.
Provide technical support in investigations of product quality complaints.
Cross-functional collaboration with Drug Product Development to ensure form, fit and function of the pre-filled syringe in a drug-device combination.
Support process improvements, including drafting or revising SOPs and contributing to departmental best practices.
Active involvement in the Technical team’s ambition to:
Establish in-house device 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 in mechanical engineering or other relevant scientific or engineering field.
Minimum of 10 years of relevant work experience, of which at least 5 years are from medical devices and/or combination products.
Technical analytical skills with a capability to understand and evaluate engineering/test data.
Strong understanding of design control frameworks, including DHF management, design verification/validation, risk management, and usability engineering.
Experience from mechanical testing and test method development is advantageous.
Commitment to contributing to Alvotech’s long term expansion and 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.
Better Access. Better Lives.
Our mission is to improve patient lives and the sustainability of the global healthcare ecosystem by broadening the availability and accessibility of biosimilars.
Offices: Saemundargata 15-19, Reykjavik, - 101, IS · Thurgauerstrasse 54, Zürich, - 8050, CH · Karl-Heinz-Beckurts-Str. 13, Jülich, - 52428, DE · 1201 Wilson Blvd, 2130, Arlington, Virginia 22209, US · Feodor-Lynen Straße 35, Hannover, Hannover 30625, DE
Better Access. Better Lives.
Our mission is to improve patient lives and the sustainability of the global healthcare ecosystem by broadening the availability and accessibility of biosimilars.
Offices: Saemundargata 15-19, Reykjavik, - 101, IS · Thurgauerstrasse 54, Zürich, - 8050, CH · Karl-Heinz-Beckurts-Str. 13, Jülich, - 52428, DE · 1201 Wilson Blvd, 2130, Arlington, Virginia 22209, US · Feodor-Lynen Straße 35, Hannover, Hannover 30625, DE
