Associate Engineer System Lifecycle (f/m/x)
The Engineer System Lifecycle collaborates closely with other departments to ensure the system functionality in routine and extra-routine phases, involving the Suppliers to implement improvements or problem fixing, and leading or supporting quality investigations and remediations. He/She is the Subject Matter Expert, Single Point Of Contact and System Owner for DLS (Data Logging System), Tulip (e-MBR) and responsible for automation compliance topics and related process (focus but not limited to).
Main Responsibilities:
* Domain expert for new and existing DLS (Data Logging System), Tulip (e-MBR) and highly automated systems used in manufacturing processes at the Bern site.
* Preparation, review and approve technical and GMP related documentation (such as SIA, URS, FMEA, impact/risk assessment) in collaboration with internal partners and system suppliers.
* 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.
* Explains work with independent analysis and conclusions related to assigned tasks through written and oral communication.
* Organization of meetings and status reporting, leading the System Owner Agenda and coordinating with different teams and coworkers to accomplish tasks.
* Support in the creation, processing, tracking and closing of ETS records (NC, CAPA, CC) related to production systems and equipment, ETS record ownership as needed.
* C&Q, CSV and Validation: input on assessments and plans, support on protocol execution.
* Supports Compliance team with SOP, WIs, Job aids harmonization initiatives across site.
* Leads in troubleshooting and resolving equipment, systems, and process problems to prevent the occurrence of product and process nonconformities.
* Input, review and sign off on design documentation with support of Sr team members as needed.
* Organizes training to the users (both coordinating external suppliers or delivering the training in first person).
* With the Manager support, review of Service Level Agreement with the Supplier.
* Ownership of the system Log Book, with regular inspections to verify it's correctly filled in and updated.
* With the Manager support, coordination of maintenance intervention including closure of WorkOrders, optimizing maintenance budgets, maintenance plans, long term equipment replacement plans, and spare part sourcing strategies.
* Responsibility for updating/maintaining master data in SAP.
* Support compilation of costs for CAPEX and OPEX application (supplier quotations, purchase order and internal workload estimation).
* Support for inspection readiness, requests from internal and external audits/inspections, and follow-up performing assigned actions, as needed.
Qualifications:
Must Haves:
* MSc degree with 0-2 years relevant experience in life sciences.
* BSc degree with 2-5 years relevant experience in life sciences.
* At least 2 years of experience in GMP compliant biotechnological manufacturing or development.
* Fluency in English.
* Fluency in German is a plus.
* Knowledge of GMP-requirements and their technical implementation in cleanrooms.
This job based in Bern, Switzerland will initially be limited to approx. 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, progressive, and collaborative environment, then send us your application today. Or give us a call if you have any questions!
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