Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.

Engineer System Lifecycle (M/F/D)

(Ref: 2406221151W)

YOUR responsibilities & YOUR impact:

Aim of this role

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).

General Activities

General

§ 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

§ 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

§ 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

§ Supports Compliance team with SOP, WIs, Job aids harmonization initiatives across site

§ Disseminates information with some guidance and exchanges information through written and oral communications

For the system Owned

§ Organization of meetings and status reporting, leading the System Owner Agenda and coordinate with different teams and coworkers to accomplish tasks

§ Develops process excellence techniques to identify systematic issues. Tracks trends, develops and implements equipment and/or process enhancements that will improve efficiency and equipment reliability C&Q, CSV and Validation: input on assessments and plans, support on protocol execution

§ 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

§ 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

§ 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

Degree of Supervision

§ Works with weekly autonomy for long term activities independently interpreting data, identifying project needs, and proposing solutions;

§ May lead or teach others on team regarding processes, techniques or tasks

Qualifications

We would love to hear from YOU, if you have:

Essential

Key competencies required

• Fluency in English
• Fluency in German is a plus
• Basic understanding of finance and cost control
• Experience in project management is a plus
• Knowledge of GMP-requirements and their technical implementation in cleanrooms

This is what awaits YOU at J&J:

• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Many opportunities to work on challenging projects and assignments.
• Possibilities for further personal as well as professional development.
• Many employees benefits.