Manager Commissioning

vor 22 Stunden

Bern, Schweiz Johnson & Johnson Family of Companies Vollzeit

Janssen Vaccines, branch of Cilag GmbH International is recruiting for a Manager Commissioning & Qualification, located in Bern, Switzerland.

We develop and deliver innovative biopharmaceutical products based on bacterial and viral technologies. Our goal is to help people live happier and healthier lives. The Technical Services business unit plays a crucial role by providing the required physical infrastructure, utilities, control systems and services. Our growing portfolio of investigational and commercial products drives significant capital investments, rendering this position an excellent opportunity to make a difference. Join us and help the site prepare for an even more exciting future

**Tasks and Responsibilities include**:

- Defines the risk-based commissioning and qualification strategy for production / laboratory equipment, facilities and utilities and puts this into action from end-to-end.
- Ensures oversight on the C&Q of new, upgraded or existing assets incl. all required documentation within a given timeline and budget
- Provides support to writing and execution of Impact Assessments, DQ’s, IQ’s, as well as OQ’s activities
- Supports creation of Change Control’s, URS’s, FMEA’s as well as Validation Documents and PQ’s
- Participates in inspections as well as audits and drives investigations, deviations, corrective and preventive actions towards successful and compliant closure
- Assures compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards
- Provide leadership and act as true expert in the field C&Q
- Manage strategic partnerships with contractors and vendors
- Leads and develop associated engineers, technicians, or external contributors
- Actively participates in the Technical Services Leadership team and corporate initiatives

**Qualifications**
- Degree in Engineering, Science or related discipline; Masters preferred.
- 6-10 years of experience in pharmaceutical plant based or consultancy role
- A minimum of 5 years’ experience in leading commissioning and qualification activities
- A minimum of 3 years of proven project management experience
- Previous experience with international health authority inspections as well as internal and external audits
- Self-driven and able to set own targets
- Ability to set priorities under pressure
- In depth knowledge of current GMP standards and guidelines related to equipment, utilities and facilities commissioning and qualification (e.g. ISO, EN, ICH, FDA, ISPE)
- Previous experience working in a large matrix-managed environment preferred
- Previous experience with Trackwise, SAP and TruVAULT system is preferred
- Fluent in English (written and spoken), German language at level C1 preferred
- Proactive, open team player that recognizes C&Q as a service

**Primary Location**
Switzerland-Berne-Bern
- **Organization**
Janssen Vaccines AG (8851)
**Job Function**
Engineering
**Requisition ID**
2206011602W

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