Subject Matter Expert, Automation Data Specialist
For our client in Leiden, we are looking for an Automation Specialist who has demonstrable experience and affinity with analysis methodology in combination with computerized systems.
Data integrity, setting up and maintaining computerized systems as well as robotics are examples of Automation activities in support of well-functioning laboratories. You will act as a Subject Mater Expert regarding Automation topics, such as, data integrity, introduction and maintenance of systems and robotics (such as use of TECAN). You will also contribute to maintaining cGMP compliance and support the LEAN status of the team.
Tasks and responsibilities
* Responsible for the technical implementation of new systems within the organization in collaboration with other teams. Lab systems vary from (standalone) analytical equipment to complex global platform projects which connect to LIMS (Laboratory Information Management Systems). Implementation of SDMS (Scientific Data Management System) and future new paperless opportunities.
* Responsible for documenting administrator procedures, technical installation procedures and maintenance procedures.
* Responsible for data integrity, including backup and (disaster) recovery
* Provide support in case of (computerized) problems.
* Implementation of equipment from a 21CFR Part 11 compliance perspective
* takes part in Lab Systems initiatives and projects, in cooperation with the global organization and in alignment with business needs.
* Master's degree or bachelor's degree (HBO) in Life Sciences or Computer Sciences or highly experienced in a similar position.
* Minimal 2 years of work experience in Pharma with GMP and automation skills
* Background in software development and programming; Laboratory Experience is considered as a plus.
* Experience with (Computer) System Validation in a GxP environment
* Experience with the following software is considered as a plus: Empower, Softmax pro, SDMS, Deskman, LIMS, 32Karat, Trackwise, Compliancewire.
* Experience with robotics, in particular TECAN, is a plus
* Ability to engage with personnel at all levels within the organization, to build and maintain fruitful relationships
* Written and oral communication skills in English. Dutch is desirable
* Planning skills, ability to prioritize multiple commitments
* Analytical thinking and (technical) problem solving. Lean/Six Sigma experience is desirable
* Experience with GAMP5 and 21CFR Part 11 is desirable
* Pro-active, works independently, takes actions in the absence of specific instructions, and can write protocols/reports, business correspondence and procedures
the role is onsite in Leiden, person should live nearby (max 1 hour of travelling)
Name consultant Marc Philip van Ittersum
When interested please react through the application process with your English resume.
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