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
Qualifications
Required:
* 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
