Qualification & Validation Engineer – Life Sciences (DE)

Qualification & Validation Engineer – Life Sciences (DE)

ALTEN Group

Within 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 57,000 engineers, carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defence & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.

 

ALTEN Switzerland

Since 2005, with 450 current employees, ALTEN Switzerland is a reference partner in providing Engineering services to 100 world leading companies. ALTEN Switzerland’s activities cover all the main strategical areas of the Swiss market in Life Sciences, Engineering & IT Services.

 

 

 

  • Person in charge of Qualification/Validation activities: production equipment and / or utilities & HVAC, environment, cleanroom.
  • Qualification phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
  • Qualification Master plans are up to date and established for all ongoing projects.
  • Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification plans, FMEA, DQ, IQ, OQ, PQ.
  • Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification documentation).
  • Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners.
  • Coordination and oversight of external suppliers.
  • Must have : GMP knowledge
  • Must have : Bachelor / Master’s degree in pharmaceutical or biotech related industries.
  • Above 3 years of experience in qualification and validation
  • Languages: English and/or German
  • On-site work in cities: Bern, Zurich, Basel, Schaffhausen