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Senior System Engineer

Senior System Engineer

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Senior System Engineer

MSI are looking for Senior Process Engineers to join a Top Pharmaceutical Organisation based in the Switzerland. If you have any experience with DSP manufacturing and GMP within a Biotech of Pharma company and are looking for a change, then this role may be for you.

Key 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



* 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