Senior Engineer System Life Cycle (4902-KFR)

CTC Resourcing Solutions

Basel
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Senior Engineer System Life Cycle (4902-KFR)

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Senior Engineer System Life Cycle as contractor till end of 2022 (with possibility for extension) based in Bern.

The Senior Engineer System Life Cycle will collaborate closely with other department partners as GMP Operation, Technical Services and Quality to ensure the system functionality in routine (GMP operations during batch manufacturing) and extra-routine phases (periodic qualification and validation, maintenance shut-down), involving the Suppliers to implement improvements or problem fixing, and leading or supporting quality investigations and remediations.

Main Responsibilities:

  • Being domain expert for new and existing system related to DSP (Downstream Process) manufacturing of biotech products in the site of Bern
  • Preparation, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment) in collaboration with internal partners and system Suppliers
  • Support for Change Control creation and tracking of defined action items
  • Contribution to ensure that changes to systems, procedures and processes are appropriately handled such that resulting impact on equipment / systems GMP state are assessed and resolved
  • For the systems owned:
    • Coordination of maintenance intervention, optimizing maintenance budgets, maintenance plans, long term equipment replacement plans, and spare part sourcing strategies
    • Organization of training to the users (both coordinating external suppliers or delivering the training in first person)
    • Owns Deviations and CAPAs
    • Compilation of costs for CAPEX application (supplier quotations, and internal workload estimation)
    • Supports inspection readiness, requests from internal and external audits / inspections, and follow-up performing assigned actions, as needed
    • Organization of meetings and status reporting, leading the System Owner Agenda and coordinate with different teams and coworkers to accomplish tasks

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Bachelor’s Degree in an Engineering or Scientific field is required. An Advanced Degree in a related field is an asset.
  • Proficiency in English. Knowledge of German is desirable.
  • A minimum of 3 years of working experience in pharmaceutical development or pharmaceutical manufacturing
  • A minimum of 1 years of working experience related to DSP equipment (ÄKTA / AxiChrom purification systems, centrifuges)
  • Knowledge of activities related to equipment qualification and process validation
  • Proficiency using MS Office Suite (Word, Excel, etc.), experience with various IT-tools is desired
  • Hands-on engineering and ability to influence AND collaborate within an open and transparent environment 
  • Experience with SAP, TruVault and Trackwise or equivalent is a plus
  • Understanding of automation related topics is a plus
  • Basic understanding of finance and cost control is a plus 
  • May require up to 5% domestic and international travel

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

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  • CTC Resourcing Solutions

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