You have a degree from an engineering school, a 5-year degree or a Faculty of Pharmacy, with a focus on quality management, drug quality, and quality risk management.
You have a strong appetite for complex projects and problem solving. Your curiosity and your technical culture are recognized in the professional environment but also in the personal environment. You have an easy questioning and are constantly looking for ways to improve.
You undertake, carry out projects and commitments. You challenge your methods and ideas to surpass yourself and reach a high level of excellence. In this context, your drivers can be technical, financial or human, you will be valued on your performance and/or that of your team.
This position is open to people with disabilities, adaptations of the position can easily be put in place.
Remuneration will be based on years of experience and specific technical expertise. To support the team in implementing a computerized systems validation strategy. (CSV), you are able to take the lead on all or part of the following business responsibilities:
Validation of PLCs, supervisors and MES (Manufacturing Execution System)
Functional analysis
Writing test protocols, change control and validation reports
Execution of IQ OQ PQ tests
GAMP, 21 CFR part 11, GMP compliance
Interface with suppliers and/or customers
You are familiar with reference systems (GMP, 21 CFR Part11, GAMP) and with specific regulations in the field of computer validation.
You have already written test sheets and participated in qualification tests. Our CSV engineers are involved in the management of QHSES & Compliance activities. We currently handle large-scale projects in many fields such as pharmaceuticals, medical devices, biotechnology, nutraceuticals, etc. Our expertise applies to production and/or project management, particularly in complex technical environments.
Our interventions are based on technical issues related to the following dimensions:
Quality system & Regulatory
Operational, product & Supplier Quality
Audit, Certification & Training
Cybersecurity
HSE
Qualification, tests & validation
