Senior Engineer Mfg Science Drug Product // Johnson & Johnson
Posted: 06 Feb 2024
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 Johnson & Johnson 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.Johnson & Johnson Innovative Medicine is a global pharmaceutical 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
Who we are looking for:
- University degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience.
- 3+ years background in biopharma production environment regulated by cGMP standards, preferably in manufacturing operations and/or Quality Control.
- Skilled in supporting pharma process investigations, technical writing and determining root cause through analysis.
- Analytical thinking and problem solving attitude combined with good teamwork capabilities
- Experienced in Root Cause Analysis tools (e.g. 5 Why, Fishbone, Kepner-Tregoe)
- od complex conflict resolution, problem solving in a cross functional setting. Ideally certified 'Green' or 'Black' belt lean-six sigma.
- Ability Excel in a quality driven organization
- Can prioritize multiple assignments and changing priorities.
- Fluent English and German communication
This job based in Bern, Switzerland will initially be limited to 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, progressive, and collaborative environment, then send us your application today. Or give us a call if you have any questions!