Laboratory System Specialist FMX
Laboratory System Specialist FMX
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Job Description
We are currently looking for passionate people ready to make a difference in the following open position: Laboratory System Specialist F/M/X based in Lyon 7e).
Within Nemeras Innovation headquarters you will manage the laboratory equipment pool with particular attention to system software and applications (integration of new instruments qualification maintenance in particular validation of laboratory system) with support of the Laboratory System Engineer.
This position reports to the Laboratory Manager.
Job Description:
- Define in collaboration with Laboratory expertise operational teams and the Laboratory Manager the annual validation master plan for the implementation of qualification and validation of new equipment & software.
- Suggest and manage the acquisition of new instruments according to the laboratorys operational needs.
- Manage and execute qualification/validation activities on laboratory equipment and associated software to required standards.
- Carry out followup activities relating to existing equipment and software such as maintenance periodic checks/calibrations interfacing with suppliers etc.
- Train laboratory team members in the use of new laboratory systems and equipment.
- Participate in the validation strategy for analytical methods within a project.
- Participate in project integration activities within the Laboratory Information Management System (LIMS).
- Participate in activities to update and improve the Laboratory Information Management System (LIMS) (including validation).
- Actively participate in continuous improvement activities within the laboratory such as implementation of best practices integration of new tools training etc.
- Create or review methods protocols to perform appropriate functional testing and measurements on projects parts.
- Impact on Quality : Maintain the qualified status of the software measuring equipment and associated equipment
- Involved in Audit on Laboratory System Software validation
Qualifications :
Youll help us achieve our corporate growth goals by bringing these skills to Nemera:
Required profile:
- Engineer degree or experienced technician (ideally 5 years) in physical measurements or quality.
- Strong knowledge and experience in software validation according to pharmaceutical requirements (EU GMP Appendix 15/21CFR Part 11.
- Good understanding of analytical systems and measuring equipment.
- Knowledge and experience in laboratory physical testing and metrology in data analysis for industrial applications.
- English fluent in professional context (internal and supplier international contacts and to understand technical documentation written in English).
- Main computer skills: Office tools equipment such as (Viota/Test Expert/Lab X/Vector Pro RT Sizer).
- Knowledge in statistical tools and analytical methods validation
- Knowledge in analytical equipment qualification according to pharmaceutical requirements.
Skills :
- Organized and rigorous.
- Able to define strategy and manage actions plan with respect to agreed timeline.
- Able to deal with prioritization changes to comply with project priorities.
- Able to adapt to new measuring instruments/software.
- Able to work with a high level of autonomy and excellent relationship skills.
- Team work oriented but also selfmotivated
- Good communication skills proactively share improvement proposals.
- Able to train crossfunctional teams.
- Able to enforce standards.
- Strong leadership convincing and communication abilities
If you are:
Passionate about growing a business
Enjoy working as a team
Proud to make products that improve patients lives
And go the extra mile to deliver on your commitments
Then youll be successful here!
Please send your resume in English.
Additional Information :
Our Recruitment Process
We believe in a transparent and straightforward recruitment process to ensure a great fit for both you and our team.
Heres what you can expect:
CV Review: Upon receiving your CV our Talent Acquisition Team will review it to assess your qualifications for the role.
Initial Screening: If your profile matches our requirements youll be invited for an initial screening call with a member of our Talent Acquisition Team.
Interview with Hiring Manager: After the initial screening youll have an interview with the Hiring Manager to discuss your experience skills and fit for the role in more detail.
Interview with N2: Following the Hiring Manager interview youll meet with the next level of management (N2 for further evaluation.
HR Manager Interview: The final step involves an interview with our HR Manager to discuss company culture benefits and other HRrelated topics.
Offer: If all goes well youll receive an offer to join our team!
We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group if you want to discover more about Nemera please look at our website
Know someone at Nemera We have a Referral Program so be sure to have them submit you as a referral prior to applying for this position!
Chez Nemera nous valorisons la diversit et linclusion et nous nous engageons crer un environnement de travail o tous les employs sont traits avec dignit et respect.
Nous sommes fiers dtre un employeur offrant lgalit des chances et nous encourageons les candidatures de toutes les origines genres orientations sexuelles ges et capacits.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
