Johnson & Johnson Careers
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Commissioning & Qualification Manager
Requisition ID: 1805635179W
"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 are anchored in the internationally applicable Credo
Janssen Vaccines AG (formerly Crucell), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide.
For our site in Bern we are looking for a highly committed
Project Manager Commissioning & Qualification
This role is responsible for setting strategy, leveraging best practices, and developing internal as well as external partnerships for commissioning and qualification (C&Q) within the engineering organization serving the Berne site. The role will manage the base business C&Q activities and support all projects with GxP-relevance through their stages of the lifecycle. In addition, the role holder creates and sustains continuous procedural improvements in order to boost efficiency of C&Q activities while further advancing our compliance level. The ideal candidate will possess a strong track record in commissioning and qualification, business acumen and a willingness to be hands-on in key aspects of C&Q tasks. The role requires the development of strong partnerships and heavy interfaces with Production, Development Quality as well as Environment Health & Safety functions on site.
- Defines the risk-based commissioning and qualification strategy for production / laboratory equipment, facilities, utilities and Computerized Systems (CSV) and puts into action from end-to-end.
- Performs the C&Q of new, upgraded or existing assets incl. all required documentation within a given timeline and budget
- Writes and executes Impact Assessments, DQ’s, IQ’s, OQ’s as well CSV 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, regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies
- 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
- 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 Documentum system is preferred.
- Fluent in English (written and spoken), German language at level C1 preferred
- Proactive, open teamplayer that recognizes C&Q as a service.
Janssen Vaccines AG (8851)