C&q Engineer

hace 1 semana

En remoto, España NonStop Consulting A tiempo completo

**C&Q Engineer**

Our client, an innovative biotechnology organization, is seeking a C&Q Engineer to join their Engineering department You’ll be joining a dynamic and international organization, situated in a gorgeous city in Europe

This is an excellent opportunity to join an organization dedicated to making medicine more accessible and affordable, so your work here will be truly impactful

**Responsibilities**
- Perform both commissioning and qualification/re-qualification activities for sterilization/sanitization equipment (autoclaves, VPHP transfer chambers, etc.).
- Perform both commissioning and qualification/re-qualification activities for temperature-controlled equipment TCUs (freezers, fridges, cold rooms, storage areas, and incubators).
- Perform periodic qualification reviews of manufacturing and infrastructure equipment.
- Develop and improve C&Q processes and author, and update SOPs and related documents.
- Manage change controls, deviations, and CAPA activities.
- Perform investigations of discrepancies arising during qualification activities and approval of appropriate corrective actions.
- Follow SOPs as required.

**Requirements**:

- Prior experience in commissioning and qualification including temperature mapping and autoclave qualification.
- Prior experience in GMP-regulated environments. Knowledge of key GMP processes is required which includes documentation, qualification, change management, user requirement specifications, and IQ/OQ/PQ execution.
- Experienced with GMP documentation and handling of deviations.
- Excellent verbal and written communication skills.
- Strong analytical skills.
- **Applicant is legally eligible to work in the EU.**

If this role sounds like something you would be interested in, please send your CV, ideally in Word format, via this site.

If this role is not quite right for you but you would like to have a conversation about other roles, please search and connect with me, Tyler Magalhaes, on LinkedIn.

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