Senior Associate II, Quality Engineering (m/w/d)

Vertragsart:
Vor Ort
Start:
04/2021
Dauer:
keine Angabe
Von:
Real Staffing
Ort:
Solothurn
Eingestellt:
08.04.2021
Land:
flag_no Schweiz
Projekt-ID:
2086197


Senior Associate II, Quality Engineering

Location: Solothurn

Duration: 3 months

Tasks:
  • Responsible for supporting the setup and structure of the automation and MES systems (Delta V and Syncade)to enable the start-up, commissioning and validation of the new Large Scale Manufacturing facility
  • Review and approve GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) specifically related to automation and MES systems (Delta V, Syncade, etc.)
  • Provide support to multiple areas within the facility; requiring a good working knowledge of regulatory and Company´s Quality and Process systems as well as working knowledge of key automation/MES systems
  • Ensure adherence to internal procedures for facility/equipment controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover, etc.)
  • Performs Quality review and approval of change control documents and activities associated with change control


Requirements:
  • Bachelor's Degree in relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer Science
  • Approximately 8 - 10 years of experience in pharmaceutical or biotech manufacturing environment. Previous experience within Quality Assurance, Validation, Automation or related function is preferred.
  • Maintain knowledge of relevant FDA/EMA regulations and compliance.
  • Approximately 3 years of experience in pharmaceutical or biotech manufacturing environment.
  • Previous experience within Quality Assurance or related function is preferred.
  • Good communication skills in English, verbally and written.
  • Technically oriented role including experience of the validation of laboratory, production equipment automation systems and knowledge of production methodology involved in biopharmaceutical production.
  • Self driven, demonstrated ownership and responsibility for work assignments.
  • Value teamwork at all levels and performs work with an open mind inviting input and feedback from partners across the organization. Ability to work with colleagues across the organization.


Sthree Switzerland is acting as an Employment Business in relation to this vacancy.