Adv. Consultant/Engineer (CP17)
ALTRAN
Basel
vor 14 Tg.

Avec plus de 45'000 consultants dans le monde et générant un chiffre d’affaires d'EUR. 2.9 Mia, le Groupe Altran est le leader mondial dans les services d’ingénierie et de R&D (ER&D).

En Suisse, Altran emploie plus de 250 consultants et vise une forte croissance avec des bureaux à Zurich, Bâle, Lausanne et Genève.

Altran déploie son expertise notamment dans les secteurs suivants :

  • Sciences de la vie (Pharma, Biotech, et Dispositifs médicaux),
  • Industrie, Aéronautique, Automobile, Energie, Transports Ferroviaire,
  • Services financiers : Assurance des personnes et des biens, Assurance maladie, Réassurance, Banque
  • Secteur public
  • Titre du poste C&Q Engineer (m / f)
  • Numéro de référence 14135
  • Lieu de travail Suisse / CHE - Toutes régions /
  • Zürich
  • Type de contrat CDI Temps plein
  • Nombre minimum d’années d’expérience requis 5 ans d'expérience et plus
  • Notre offre

  • A permanent contract with the leader in innovation and high-tech engineering consulting
  • A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR.
  • 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).

  • In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
  • Altran deploys its expertise particularly in : Life Sciences (Pharma, Biotech, and Medical Devices), Industry, Aerospace, Automotive, Energy, Railways, Financial Services : P&C Insurance, Health Insurance, Reinsurance, Banking Telecoms Public sector
  • Vos responsabilités

  • Subject Matter Expert (SME) in terms of qualification and validation for utilities and equipment.
  • Manage or execute equipment, utility and facility qualification activities related to the implementation of system changes and new systems according ASTM E2500.
  • Responsible for Experience with all pertinent industry best practices (e.g., GAMP) including development and execution of all applicable system life cycle deliverables (e.
  • g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).

  • Key responsible person for the integration of an automation revamping project : project management, automation development integration follow up, Hardware & electrical installation, commissioning, validation and deliverables.
  • Maintain equipment to support GMP manufacturing ensuring all equipment complies with Standard Operating Procedures and Policies.
  • Participate in project planning, scheduling, and tracking.
  • Develop and implement procedures to comply with corporate and industry standards.
  • Provide validation training to Operations employees.
  • Votre profil

  • M.Sc. in in scientific or engineering discipline
  • Minimum 7 years of experience in Qualification / Validation in the Pharmaceutical industry
  • Applied knowledge of FDA and international Pharmaceutical regulations is preferred
  • Applied technical understanding of manufacturing equipment as black utilities, HVAC, clean utilities (WFI, Pure Steam, Pure Water, CAP loops ).
  • Demonstrate expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, and GMP) and internal requirements employing regulatory guidance and industry standards.
  • Demonstrated problem solving and troubleshooting skills
  • Languages : English fluent and German is clearly a plus
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