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Unlock Your Potential as a Senior Automation Specialist
Cerba Research Netherlands is seeking a highly skilled and innovative Senior Automation Specialist to join our dynamic Laboratory Operations team. As a key member of our team, you will play a crucial role in developing and implementing automation strategies to drive operational excellence and improve efficiency in our laboratory processes.
Your Key Responsibilities:
As a Senior Automation Specialist, you will be responsible for leading the development and implementation of automation activities that increase the throughput of our assays. This will enable us to meet the demands of our clients at different phases of clinical intervention studies against viral infections. Your key objectives will include:
Development of Automation Systems:
- Develop automation of plate-based assays (96- and 384-well format), and demonstrate equivalence of results across systems.
- Proposal for acquisition of (new) equipment that is demonstrably better, allowing higher throughput and quality of results.
- Collaborate with software developers for the programming of instrument interfaces and data capture pipelines.
- Work with end users to enable efficient use of laboratory systems.
- Management of automation projects, including planning of resources and budget, and setting timelines and assigning responsible people for each deliverable.
Implementation of Automation Systems:
- Demonstrate equivalence of results across systems e.g. acquired vs existing equipment.
- Support the validation and implementation of new computerized systems that are 21 CFR part 11 compliant, including writing and reviewing validation protocols and reports.
- Advise on the correct application of internal and external regulations for computer system projects.
- Provide day-to-day operational support for automation systems, troubleshoot issues, and coordinate deviation, change control, and/or corrective actions.
- Audit computerized systems at the site and monitor the implementation of corrective and preventive action plans.
- Ensure adequate standards are maintained, communicated, and effectively implemented for all systems and associated computer infrastructure.
Your Qualifications:
- Bachelor or Master's degree in either virology, engineering, robotics or data science
- > 5 years experience working in a similar position (field application specialist, or system service engineer) that involves the implementation of automation systems in a GCLP regulated environment.
Recognized Competences:
- Problem solving mindset to tackle arising automation challenges.
- Project management skills with clear and concise communication on progress of activities.
- Lead technical discussions with providers of automation solutions and guide internal stakeholders for implementation of new systems.
- Experience in training technical automation teams.
- Strong verbal and written command of English at an advanced level.
- Good planning and organizational skills
- Familiarity with best practices set by GAMP-5 and 21CFR11/Annex 11 to maintain data integrity.
- Experience in the field of GLP, GCLP, GAMP and ISO17025 is compulsory.
About Us:
Cerba Research is a leading organization in the field of virology and molecular biology, dedicated to advancing world health through innovative research and development. Our team of experts is passionate about delivering high-quality results and making a meaningful impact in the fight against viral infections. As an equal opportunity employer, we are committed to promoting the growth and development of our employees and providing a dynamic and inclusive work environment.
