SITE QUALITY MICROBIOLOGIST.

Job content

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.

Site Quality Microbiologist (M/F/D)

(Ref: 2105968788W)

Location : Berne

Permanent Contract : 100%

We are looking for a Site Quality Microbiologist. This role is to provide expertise in microbiological control aspects for manufacturing and sterile processing. The incumbent reports directly to the Site Quality Head. The main mechanisms for providing leadership into the Bern Vaccine site in the application and interpretation of sterility assurance standards and through contribution to the development of the Quality Management System as it relates to sterile manufacture.

The Site Quality Microbiologist functions as the focal point for all microbiological quality & compliance activities at Janssen Vaccines, Bern.

YOUR Responsibilities & YOUR Impact

• Establish and maintain the site`s microbiological and viral contamination prevention and control programs.
• Ensure that microbiological quality of products, manufacturing facilities, and utilities meet company, local and global requirements.
• Develop and deploy strategies and measures crafted to ensure a continuous state of contamination control and sterility assurance across the site.
• Provide technical, scientific, and strategic leadership and support to cross-functional teams and critical business partners including Quality unit, Quality Control, manufacturing operations, AD/PD, cell-banking, engineering, regulatory affairs, and others with all microbiological topics and microbial-based projects.
• Grow the site’s Microbiology competence, capability, and capacity.
• Keep yourself up to date with new regulations, trends, and best industry practices in relation to sterility assurance.
• Collaborate and network with the global Microbiological Sterility Assurance organization
• They will provide the on-site Quality and compliance oversight of production activities (specialty API, bulk drug substance, analytical testing, drug product, packaging) to ensure J&J standards are met, to safeguard J&J’s patients, to protect J&J’s reputation.
• Author/Review/Approve documents from processes and provide leadership and management to these processes.
• Own the site “Microbial Control Strategy and Response Committee”; accountable for Sterility Assurance; Biocontamination Control; Aseptic Competence; Hygiene and Gowning; etc.
• Makes decisions on nonconforming processes/products, identifies, and resolves compliance risks, and help R&D and SC groups to comply with local, global, internal, and external regulations.
• Lead the deployment of Quality work-tools (Event Management; Risk-assessments; CCs; CAPAs, etc.) when taking care of microbiology-related non-conformances to warrant compliance and adherence to local, global, and HA requirements.
• Author/Review/Approve study plans; analytical methods documents; specifications; memos; assessments; etc. as an SME, consultant, team-member, or team-leader of the relevant project.
• Support supplier audits and vendor qualification activities.
• Act as a SPOC for the Janssen Sterility Assurance organization.
  
  

Qualifications

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

• Master’s degree in Microbiology, Life sciences, or equivalent technical subject area is required, PhD in related fields is a plus.
• A proven experience in Quality Assurance or other Quality unit is required.
• Microbiology/ sterility Assurance experience in a pharmaceutical environment.
• Extensive knowledge of trending of environmental monitoring data.
• Experience with aseptic processing and work in clean rooms
• Knowledge of cGMP regulations and FDA/EU guidelines related to manufacturing of Large Molecules/Vaccines as well as knowledge of USP/EP chapters related to microbiological test methods.
• Good written and verbal communication skills are required, English is a must, German would be an advance.
• Experience in clinical quality, method development, cell banking, or Research & Development is helpful.
• Strong interpersonal skills
• Broad and in-depth scientific expertise
• Analytical and scientific-based approach to problem solving.
• Strategic and concrete methodology for project leadership and management.
• Proactive approach to reshape and question norms and habits.
• Engaging, stimulating, management style without direct leadership
• Ability to prioritize and to endure peak times.
• Creative and welcoming change, recognize evolutional processes and use it to introduce improvements and enhancements to customary routines and processes.
• Flexible, pragmatic, however determined to set aims and reach goals.
  
  

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.
  
  

Primary Location

Switzerland-Berne-Bern-

Organization

Janssen Vaccines AG (8851)

Job Function

Quality

Requisition ID

2105968788W