System Integration Specialist
Role details
Job location
Tech stack
Job description
That's why Progenika Biopharma is looking for a System Integration Specialist who joins the System Integration team in the R&D department.
What your responsibilities will be
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Contribute to and manage system integration experiential work
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Integrate, test, troubleshoot and optimize automated system performance across full life cycle.
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Execute and design experimental work for immunoassay integration into automated systems.
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Validate and interpret experimental results.
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Contribute to the research and understanding of new immunoassay technology in automated systems.
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Support field service engineers from an immunoassay development and system integration perspective.
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Support the design and development of immunoassays projects in collaboration with other R&D Teams.
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Prepare reports and present results internally and with external partners.
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Travel and execute/supervise/guide system integration or assay technology understanding at internal or external partners
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Travel frequently to other internal or external companies to execute or supervise work.
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Inform and report of partner progress.
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Coordinate with supervisors and rest of stakeholders from R&D and other functional areas (internal and external).
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Contribute to product life cycle documentation according to QMS and Procedures
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Prepare required documents and SOPs for integration, transfer, usability etc... regarding system integration.
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Supervise instrument maintenance, IQ/OQ/PQ.
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Participate in laboratory maintenance tasks.
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Statistical analysis of results.
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Verification and validation of experimental results.
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Functionally leads a team of Lab Associates/technicians
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Direct and mentor junior personnel within their work area.
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Identify the training needs of the personnel under their responsibility.
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Ensure compliance with quality, cost, and timeline objectives related to their product/project.
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Identify the needs of their area regarding the Quality System and communicate them to the quality manager.
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Ensure full compliance with the quality system within their work area.
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Request the purchase of necessary products for their area from the purchasing manager.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
- You hold a bachelor's degree in health sciences (Biomedical Engineering, Medical Laboratory Science, Biotechnology, Biochemistry, Biology, Pharmacy or similar). PhD studies will be valued.
- You bring at least 3 years of laboratory experience.
- You have knowledge or experience in immunoassays and/or IVD devices development are desirable.
- You have high knowledge of Office package and knowledge of statistics.
- You have excellent verbal and written communication skills in the English language (CAE qualified).
- You have knowledge of Good Laboratory Practices.
- You have availability to travel and spend extended periods of time at partner´s sites.
- You must be proactive, procedure oriented, and have strong attention to detail.
- You have proven collaboration and communication skills as well as ability to work as a team member.