Senior Engineer Quality Investigations // Johnson & Johnson.

Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 120,000 people.

Janssen Vaccines, 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. The Bern site, with its approx. 600 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and bacterial based therapeutic products.

Main Responsibilities:

The Non-conformance Investigator position in MSIT aims to follow the overall process of non-conformance investigations, based on Johnson & Johnson requirements. The investigator will be responsible for the E2E investigation process: initiation, lead and writing of impact assessment, leading execution of the investigation of Medium/High Impact Non-conformances, aiming at the identification of assignable and/or root cause, as well as implementation of corrections, Corrective and/or Preventive Actions to prevent Recurrence, and effectiveness check This is the main role besides work as a process engineer/SME in the corresponding team.

• Independently lead non-conformance issuance, performance of impact assessment and respective investigation to prevent recurrences in support of Manufacturing operations.
• Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the non-conformance investigation, identification of Corrections and Corrective and Preventative Actions to reduce or prevent recurrence.
• Routine interaction with the Operations, Quality Control and other departments to communicate investigational current status, perform alignment meetings, facilitate reviews, CAPA discussions and comments resolution.
• Technical writing of investigation reports for the educated but uninformed reader, that accurately capture immediate actions and containment of the event, conclusion on the cause of the non-conformance and follow-up actions to prevent recurrence.
• Work on the manufacturing floor together with other SMEs for data gathering, observing of processes for investigations, and performance of associated interviews (e. g. operators).
• Meeting Facilitation and participation, aligning both internal and quality review team and the area subject matter experts on an agreed to investigational path forward.
• Management of multiple quality investigation projects and timelines concurrently. Ability to adhere to standard timelines, and escalate actions appropriately for resolution in a timely manner.
• Work as an SME in the corresponding team on assigned tasks and processes other than the assigned investigational leads.
• Execution and collaboration in criticality assessments, tech-transfer processes, new technology evaluation.
• Writing of GMP documentation like e.g. Master batch records and training of personnel on these documents.
• Input on validation and qualification assessments.
• Responsible for aspects of cGMP and external party inspections within manufacturing including interaction with inspectors