For one of our client, we are looking for an enthusiastic and experienced Process Control Validation Specialist.
- Do you have a University Degree in engineering, automation, IT, biological laboratory Equipment or equivalent?
- Do you have at least a first experience in both analytical and automated CSV solutions applied in R&D ?
- Are you fluent in French en in English?
Maybe you are the new colleague we are looking for!
As a Process Control Validation Specialist, you apply the right validation methodology for laboratory automated equipments qualification, respecting cGMP of EU, US and all other applicable regulations.
- You ensure proper execution of the validation methodology, the application of cGMP (Validation Master Plan, URS, RA, Design Qualification, Installation & Operational Qualification,Performance Qualification and Validation Reports) and specific regulations applicable to the “computer” domain (FDA’s 21 CFR Part 11, Eudralex Annex 11).
- You ensure the application of SOPs (Change Control, Incidents Management, Access Management, Backup and Restore,…) for the projects you coordinate.
- You manage, schedule, coordinate and track each qualification or validation activities to ensure timely completion of the validation plan in coordination with Production, Technical, Quality Control, Quality Assurance and Regulatory departments.
- You monitor that validation deviations are properly generated, managed and completed.
- You coach users, Technical Services, Validation and QA regarding validation methodology applied to automated systems.
- You have a University level (engineering, automation, IT, biological laboratory equipment…) or equivalent by experience and you have a first experience in both analytical and automated CSV solutions applied in R&D.
- You have an excellent knowledge of main laboratory automation and IT principles and components (PLC, SCADA, HMI, network, spread sheets…).
- You have an excellent knowledge of process control part of standard automated lab systems, such as HPLC, Bioreactors/fermentors, ...
- You have an excellent knowledge of regulations and standard guidelines 'cGMP), specific regulations and guidelines applicable to computerized systems (21 CFR Part 11, Annex 11), GAMP 5 on Risk Based Approach to Compliant Computerized Systems, ASTM 2500 - ICH Q9 on Quality Risk Management.
- You have a good knowledge of good practices in electronic records management.
- You have a good Knowledge of risk analysis methods applicable to computerized systems (such as FMEA).
- You have a good knowledge of projects and qualification steps, including commissioning.
- You are bilingual French/English (spoken and written).
+32 2 588 16 07