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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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!
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Caring for the world … one person at a time inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Innovative Medicine work with partners in health care to touch t
Caring for the world … one person at a time inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Innovative Medicine work with partners in health care to touch t
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