Lead Technician Gmp Operations

vor 5 Monaten

Bern, Schweiz Johnson & Johnson Vollzeit

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.

**Lead Technician GMP Operations (M/F/D)**

**(Ref: 2406168152W)**

**YOUR **responsibilities & YOUR impact**:
**Aim of this role**

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

**General Activities**
- 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 house-keeping activities (logbooks, cleaning protocols, etc.) in accordance with cGMP regulations.
- Responsible for rooms and equipments as defined in the corresponding documents.
- Establishment and ownership of WI, TRGs 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.
- Supporting process/cleaning qualification, validation work and 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.
- Support in establishment and providing feedback to study plans, study reports, SOPs, MBRs, technical and equipment maintenance/calibration reports

**Qualifications**:
**We would love to hear from YOU, if you have**:
**Essential**
- BSc degree in life sciences (pharmaceutical technology/biotechnology, food technology, chemical technology or equivalent)
- Concluded apprenticeship in the field of life (pharmaceutical technology/biotechnology, food technology, chemical technology or equivalent)
- BSc: professional experience
- Concluded apprenticeship: Several years of professional experience

**Key competencies required**
- Advanced knowledge of USP technology, cell and virus cultivation and bacterial fermentation.
- Flexible, adaptive and a team player.
- Fluency in German or English.
- Knowledge on problem solving and communication.
- Ability to work independently and self-disciplined to meet the given timelines.

**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.

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