C&q Engineer - Paris, France - Pentabell

Pentabell
Pentabell
Entreprise vérifiée
Paris, France

il y a 3 semaines

Sophie Dupont

Posté par:

Sophie Dupont

beBee Recruiter
Description

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 followup
  • 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 startup 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 nontechnical 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:
Paris 2e (Exigé)


Ability to Relocate:

Paris 2e:
Relocate before starting work (Exigé)

Lieu du poste :
En présentiel
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