Automation Specialist COVID-19 Vaccine testing

For our client, Janssen Biologics B.V., we are looking for an Automation Specialist COVID-19 Vaccine testing.

Keywords
TECAN robotics experience
GMP
CSV
B.Sc./M.Sc. Life Sciences or Computer Sciences
>2 years relevant experience

Profile
Do you want to be involved in the COVID-19 vaccine?
We are looking for an Automation Specialist who has demonstrable experience and affinity with analysis methodology in combination with automation. You will act as an SME regarding Automation topics, such as, data integrity, introduction and maintenance of systems and robotics (such as use of TECAN). Further, you will also contribute to maintaining cGMP compliance and support the LEAN status of the team.

Automation support on Lab Systems is key in ensuring well-functioning of testing activities. The quality of data management, systems processes and standards (leverage on existing and implement new technologies) need to be supported and need to be improved continually. Lab systems vary from (standalone) analytical equipment to complex global platform projects like LIMS (Laboratory Information Management Systems), SDMS (Scientific Data Management System) and future new paperless opportunities. Data Integrity is very important, therefore, user requirements of (current and new) systems need to be translated into technical specifications and systems need to follow the set DI standards. Next to that, (standard) data definitions still need to be developed to establish quality and data integrity expectations. Compliance to those expectations need to be ensured. You will work on implementation of automation products related to COVID-19 Vaccines testing in a highly flexible environment and takes part in Lab Systems initiatives and projects, all in co-operation with the global organisation and in alignment with business needs.

Who we're looking for
The ideal candidate has a B.Sc. M.Sc. in Life Sciences or Computer Sciences with at least 2 years of experience in pharma with GMP and automation skills. Candidates with TECAN robotics experience are strongly preferred!
Additionally, you need to have:

• Experience with (Computer) System Validation in a GxP environment;
• Experience with the following software is considered as a plus: Empower, Softmax pro, SDMS, Deskman, eLIMS, 32Karat, Trackwise, Compliancewire.
• Project management skills and interpersonal skills. Ability to engage with personnel at all levels within the organisation, to build and maintain fruitful relationships;
• Written and oral communication skills in English (Dutch is desirable);
• Planning skills, ability to prioritise multiple commitments;
• Analytical thinking and (technical) problem solving. Lean/Six Sigma experience is desirable;
• Pro Active, work independently, take actions in the absence of specific instruction and you are able to write protocols/reports, business correspondence and procedures.