About the position
Alvotech in Iceland is looking for an experienced Principal Automation Specialist. This role involves providing primary technical support for site control systems and working with minimum supervision. The specialist will support and coach junior engineers within the Automation team and collaborate with stakeholders across the business to identify automation support and continuous improvement needs. The position also includes facilitating the preparation of system requirements (URS/FRS) and leading continuous improvement activities/projects that are complex and/or non-routine in nature. The specialist will generate, execute, and review/approve automation test protocols and associated qualification documents as required to support CAPAs and continuous improvement activities. Additionally, the role involves interacting with and managing suppliers of manufacturing/process control equipment, authoring and reviewing procedures owned by the department, and coordinating with other departments and outside contractors/vendors to achieve delivery and qualification of automation systems. The specialist will also support automation aspects of capital projects across Alvotech sites and lead automation aspects of medium/large scale automation projects, driving best practices and providing expert technical support in areas of expertise, primarily Siemens systems.
Responsibilities
- Provide primary technical support for site control systems.
- Support and coach junior engineers within the Automation team.
- Work with stakeholders to identify automation support and continuous improvement needs.
- Facilitate in the preparation of system requirements (URS/FRS).
- Identify and own continuous improvement activities associated with automation systems.
- Lead and deliver continuous improvement activities/projects that are complex and/or non-routine.
- Generate, execute and review/approve automation test protocols and associated qualification documents.
- Interact with and manage suppliers of manufacturing/process control equipment.
- Author and review procedures owned by the department.
- Coordinate with other departments and outside contractors/vendors to achieve delivery and qualification of automation systems.
- Support automation aspects of capital projects across Alvotech sites.
- Lead automation aspects of medium/large scale automation projects.
- Drive best-practice and provide expert technical support in areas of expertise (primarily Siemens systems).
Requirements
- Minimum BSc/BEng in an engineering/technical discipline (or equivalent higher level education/training).
- Minimum 10 years relevant experience working with industrial control systems.
- Good understanding of ISPE GAMP 5 guidelines.
- Knowledge of cGMP standards and experience working in a GMP environment.
- Knowledge of and experience with FDA and/or EMA regulatory requirements in cGMP, 21 CFR Part 11 and/or EU GMP Annex 11 is advantageous.
- Knowledge of and experience of Operational/IT Infrastructure development, maintenance and qualification.
- Significant experience in the implementation and support of Siemens systems.
Benefits
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and wellbeing support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.
