Computerized Systems Validation Consultant
To strengthen the Agidens team in the Netherlands, we are looking for an experienced CSV Consultant. You will monitor the quality of processes, systems, equipment and/or software applications, used for research and production of medicines.
What will you do?
• You develop the validation strategy and carry out validation activities on an R&D site or a production plant (Bio-Tech).
• You prepare ‘high level’ documents (Validation master plans, criticality analysis), protocols and scripts, procedures and reports, up to the final delivery.
• You may be conducted to supervise a team of validation engineers in the execution of validation activities.
• You strictly work according procedures and guidelines.
• You report on the progress of these validation activities to the project manager.
Who are you?
• You preferably have at least a master or engineer’s degree in a technical or scientific field, linked to life sciences.
• You have 5 years of experience with computer validation in a GMP environment and you know how to use some of its associated applications (ex.: MES, ERP, LIMS, EBR, QMS/eDMS, etc.).
• You have broad/general knowledge on computerized systems and automation (ex.: data security, data exchange, infrastructure, PLC, SCADA, MES-systems, ERP, etc).
• You are familiar with working according GAMP 5, and aware of current insights regarding 21 CFR-part11.
• You are able to work precisely and accurately and in accordance to specific guidelines and rules (ex. GMP, GLP).
• You have good communication skills at different (social) levels.
• You are self-reliant and organized, with a team spirit.
• You have experience with MS Office.
• You express yourself fluently in Dutch and English, oral and written.
What do we offer?
• To work in a dynamic environment where you can give free rein to your inventiveness within a well-defined framework.
• To have the possibility to team up with passionate, quality on technology-driven people.
• To develop yourself in a learning environment that offers the potential for career development.
• To be part of a company culture where respect, knowledge sharing, open mind, allow to strive for excellence.
READY TO APPLY?
Completely convinced after reading this job posting? Let’s get together! Start your application here or get in touch with our recruiter. We would love to schedule a first meeting with you!
WHAT TO EXPECT WHEN YOU APPLY?
Your journey begins with your application, which we’ll attentively review and respond to with valuable feedback.
Once you meet the position’s basic qualifications, our recruiter will connect with you to schedule a video call.
Delve deeper into the role and responsibilities during a face-to-face interview with the hiring manager, who will share insights into your prospective position.
Engage with potential team members, showcasing your skills and assessing if the role is the ideal match for you.
Congratulations, we believe you’re the perfect fit for the job!
Signed & sealed! We’re thrilled to welcome you aboard our team.
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