Sr Team Leader System Life Cycle

vor 1 Woche

Bern, Schweiz Johnson & Johnson Vollzeit

For our growing site in Bern we are currently recruiting a **Systems Lifecycle Sr Team Leader **to join our team.

The **Systems Lifecycle Sr Team Leader **supervises a team of individual contributors in the execution of the System Lifecycle Process for the simple GMP systems in Bern, acting as System Owner, Subject Matter Expert and Single Point Of Contact for such systems. He / She delivers operational results that have impact on the achievement of results for the team.

**Key Responsibilities**:

- Supervises a team of individual contributors, and is accountable for conducting effective performance management.
- Assists with technical problems and ensures that remedial actions are taken whenever test systems fail to meet acceptable performance specifications.
- Responsible for leading operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within expected standards.
- 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
- Exchanges information and communicates optimally to reach agreement in ambiguous or sensitive situations.
- Leads or teaches others on team regarding processes, techniques or tasks on specific engineering fields
- Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

**Team Duties**:
The System Life Cycle team for simple GMP equipment in Bern will be initially composed by 4 team members, a few of them still to be selected. Every team member will have in his roles and responsibilities the following tasks, at different level of complexity based on his individual background:

- Domain expert for new and existing GMP simple systems used in all manufacturing processes in the site of Bern (including but not limited to: refrigerators, freezers, incubators, sealers, bench equipment...)
- Preparation, review and approve technical and GMP related documentation (such as URS, impact/risk assessment, calibration list...) in collaboration with internal partners and system Suppliers
- Ensure that changes to systems, procedures and processes are appropriately handled such that resulting impact on equipment / systems GMP state are assessed and resolved
- Creation, processing, tracking and closing of ETS records (QI, CAPA, CC) related to production systems and equipment, ETS record ownership as needed
- Support for new technology evaluation with respect to GxP Operations applicability and makes final recommendations to management
- Supports Compliance team with SOP, WIs, Job aids harmonization initiatives across site

**For the systems owned**:

- Input, review and sign off on design documentation
- Organization of meetings and status reporting, leading the System Owner Agenda and coordinate with different teams and coworkers to accomplish tasks
- 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
- Organizes training to the users (both coordinating external suppliers or delivering the training in first person)
- Ownership of the Log Book, with regular inspections to verify it’s correctly filled in and updated
- Responsibility for updating / maintaining master data in SAP
- Review of Service Level Agreement with the Supplier
- Coordination of maintenance intervention including closure of Work-Orders, optimizing maintenance budgets, maintenance plans, long term equipment replacement plans, and spare part sourcing strategies when applicable.
- Support for inspection readiness, requests from internal and external audits / inspections, and follow-up performing assigned actions, as needed

**Qualifications**:
**Qualifications**:
**Education**:
MSc degree or equivalent experience (or BSc with increased level of experience: 7-9 years) in technical or life sciences

**Experience and Skills**:
**Required**:

- Ability to work independently with limited supervision and assume personal ownership and accountability for business results and solutions
- Critical thinking and strong analytical skills with the ability to use logic and reasoning to identify the strengths and weaknesses of alternative and differentiated solutions
- Biotechnology or Pharmaceutical industry experience
- Know-how of quality assurance principles
- Experience working in project teams and multiple projects in parallel
- Able to manage multiple priorities simultaneously
- Excellent interpersonal skills
- Business proficiency in English

**Preferred**:

- Previous people management experience
- German language

**Other**:

- Travel percentage - less than 10%

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration f

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