Associate Engineer System Lifecycle

Randstad - Medium prio
Berna, Berne
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Jobdescription

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

Functie-eisen

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!

8 giorni fa