Lead Technician GMP Operations (f/m/x) // Johnson & Johnson

☞ Randstad Switzerland

View: 152

Update day: 29-03-2024

Location: Bern Bern BE

Category: Executive management Production / Operation

Industry: Staffing Recruiting Biotechnology Pharmaceuticals

Position: Entry level

Job type: Full-time

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Job content

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 is anchored in the internationally applicable Credo. 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 260 operating companies in more than 60 countries employing approximately 135,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Janssen Vaccines in Bern belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 40,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 400 people of over 25 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products. We are committed to bringing meaningful innovation to global health by combating major threats to the health of people worldwide.

The aim of this position is Process development, scale up and manufacturing at pilot scale of drug substance material complying with cGMP regulations within the upstream processing group (USP). Having a leading function for organizing and carrying out work on the shop floor, reporting, analyzing, and interpreting obtained results. Ability to make scientifically and technically sound conclusions contributing to the improvements of processes and procedures from a technical perspective.

Main Responsibilities
  • Planning, execution, and documentation of assigned project work (USP) with established procedures (MBRs, SOPs) according to good documentation practice and corresponding regulations (cGMP, ICH). To a lead technician an implicit lead function in process planning and execution can be assigned.
  • Carry out core USP processes (fermentation, separation, depth filtration, buffer preparation, equipment cleaning/setup/prep, etc.) complying to cGMP regulations.
  • Organization of the lab (GMP area), including safety and safety procedures and troubleshooting if needed. Reporting of EHS gaps and/or incidents and initiation of EHS improvements.
  • Internal organization of assigned pilot plant facility suites including implementation of safety relevant procedures as well as admin activities (logbooks, cleaning protocols, etc.) according to cGMP regulations.
  • Establishment and ownership of SOPs and manufacturing protocols.
  • Document the executed work in protocols and batch records in accordance with good documentation practice, report documentation gaps and act upon them depending on defined responsibilities.
  • Accurate interpretation of batch manufacturing results/data. Concluding on results with the process engineer or the scientist/team leader thus contributing to campaign reporting and to process and operational improvements.
  • Reporting of non-conformances.
  • Communication with internal and external parties for raw material supply as well as for purchasing and commissioning of new equipment.
  • Supporting process/cleaning qualification, validation work and equipment qualification and computerized system validation activities.
  • Supporting equipment qualification and computerized system validation activities.
  • Implementing new techniques and technologies, staying up to date with novel technologies related to the work area, maintaining a spirit of continuous improvement.
  • Key role in writing MBRs.
  • Support establishment and feedback to study plans, study reports, SOPs, MBRs, technical and equipment maintenance/calibration reports.
  • Initiating quality issue records and low impact investigations as well as corrective actions.
  • Initiating Change controls and CAPAs.
  • Execution of Batch record review I (BRRI).
Who We Are Looking For
  • BSc or MSc degree in life sciences or concluded apprenticeship in the field of LifeScience with several years of professional experience
  • Knowledge of USP technology, cell and virus cultivation and bacterial fermentation is a major plus
  • Flexible, adaptive and a team player
  • Good level of communication in German and English.
  • Knowledge on problem solving and communication.
  • Ability to work independently and self-disciplined to meet the given timelines.
This job based in Bern, Switzerland will initially be limited to approx. 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!
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Deadline: 13-05-2024

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