Associate Engineer System Lifecycle
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 coordinate 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
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- qualifications
Must Haves:
- MSc degree 0-2 years relevant experience in life sciences
- BSs degree 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!
- +41 31 547 10 95
- Randstad JnJ Bern
