C&q Engineer

il y a 6 jours

Paris, France Pentabell Temps plein

**Responsibilities**:

- Perform C&Q in accordance with GFD procedures, best practices, specifications, and project planning
documents.
- Preparation of documents associated with C&Q activities.
- Preparation and execution of FAT, and SAT protocols
- Review equipment specifications to ensure FAT, SAT and PIM requirements are included, as appropriate.
- Design Qualification (DQ) protocol preparation, execution, and follow-up
- Preparation and execution of Qualification protocols (IQ,OQ, PQ)
- Field Walkdowns of systems as part of transfer of ownership of the system from Construction
- Ensuring safe operation of the system prior to and during start-up functional testing and Qualification phases
- Nonconformity management during project lifecycle
- Summary Report writing
- Organize and review daily tasks/verifications and track the progress of the activities assigned.
- Contractors and/or Vendors coordination
- Interfacing with representatives on project team, Construction, Engineering, Automation, Quality and End
Users during the different project phases.
- Collaborate with Automation contractors in support of integrated C&Q/CSV approach.
- Provide weekly status updates to C&Q Material Preparation Lead
- BS Engineering (or equivalent experience)
- 5 years working in a pharmaceutical environment and if possible, in a sterile process.
- Minimum 5 years C&Q experience
- One significant experience in Qualification of Autoclave, Washer or Component processor
- Good knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
- One significant experience in Commissioning & Qualification of Isolators packages
- Good written and verbal communication skills with both technical and non-technical staff
(French+English)
- KNEAT knowledge is a plus for the position.

Type d'emploi : Temps plein

Salaire : 30 109,11€ à 53 710,02€ par an

Avantages:

- Prise en charge du transport quotidien
- RTT
- Travail à domicile occasionnel

Programmation:

- Travail en journée

Formation:

- Bac +5 (Master / MBA) (Optionnel)

Expérience:

- Ingénierie de projets: 1 an (Optionnel)

Langue:

- Espagnol (Optionnel)
- Allemand (Optionnel)
- Anglais (Optionnel)

Ability to Commute:

- 30016 Paris 2e (Exigé)

Ability to Relocate:

- 30016 Paris 2e: Relocate before starting work (Exigé)

Lieu du poste : En présentiel

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