C&Q Engineer (m/f)
ALTRAN
Basel
vor 13 Tg.

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
  • Public sector
  • Job Title C&Q Engineer (m / f)
  • Vacancy Reference Number 14135
  • Work Site Switzerland / CHE - All Regions /
  • Zürich
  • Contract Type Permanent Full-Time
  • Minimum number of years of experience required 5 years of experience and more
  • Our offer

  • 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
  • Your role

  • 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.
  • Your profile

  • 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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