Lead Technician GMP Operations

at  Johnson Johnson

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: 2406220737W)
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) or downstream processing group (DSP) of the GMP operations department. Planning and carrying out of the practical work; Continuous process improvement; Reporting and managing of quality issues; Manufacturing documentation review; Generation and update of manufacturing and process supportive documentation

General Activities

• Execution of the practical upstream or downstream project work within a cGMP regulated environment. To a lead technician, an implicit lead function in process execution can be assigned.
• Reporting and interpretation of batch manufacturing results. Conclude on results in consultation with the process engineer or the scientist/team leader contributing to process and operational improvement.
• Carry out development and manufacturing activities according to predefined study plns or batch records complying to the defined timelines.
• Carry out core USP processes (small scale aseptic mammamlian cell culture in roller bottles or shaker flasks, operation of small scale bioreactors (10, 20, 50 L), equipment preparation, buffer preparation, infection of cell culture using viruses, cell harvest or DSP processes (filtration, chromatography, cross-flow filtration, centrifugation, buffer preparation, filling etc.) according to cGMP.
• Support process/cleaning qualification and validation work.
• Establishment and ownership of SOPs and manufacturing protolcs.
• Perform Work according to EHS regulations, report EHS gaps and/or incidents and initiate EHS improvement.
• Document the executed work in protocols and batch records in accordance to good documentation practice.
• Review filled out batch records and manufacturing protocols.
• Plan the execution of work packages and manufacturing operations as well as side activities.
• Take part in establishment and provide feedback to study plans, study reports, SOPs, MBRs, technical and equipment maintenance/calibration reports.
• Report quality documentation gaps and act upon them depending on defined responsibilities.
• Implementation and introduction of new processing techniques and manufacturing equipment and/or coordination of equipment improvements and modifications.
• Communication with external parties for purchase of new equipment and materials.
• Support equipment qualification and computerized system validation activities.
• 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 to cGMP regulations.
• Reporting of non-conformances and initiation of quality issue records and low impact investigations as well as corrective actions under cGMP.
• Responsible for SAP material ordering and consumption.
• Execution of on-call duty

QUALIFICATIONS

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

Essential

• BSc or MSc degree in life sciences (pharmaceutical technology/biotechnology, food technology, chemical technology or equivalent) or concluded apprenticeship in the field of life (pharmaceutical technology/biotechnology, food technology, chemical technology or equivalent) with several years of professional experience
• Professional work experience as technician with leading responsibilities or equivalent in the life sciences field in a cGMP environment.

Key competencies required

• Flexible, adaptive and a team player
• Ability to work independently and self-disciplined to meet the given timelines
• Language skills: good German skills and fluent English spoken and written.
• Previous experience with upstream pharma processing operations (aseptic processing, mammalian cell culture, different modes of bioreactor operations e.g. perfusion, etc.) or downstream technologies (filtration, chromatography etc.)

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.

• Process development, scale up and manufacturing at pilot scale of drug substance material complying with cGMP regulations within the upstream processing group (USP) or downstream processing group (DSP) of the GMP operations department. Planning and carrying out of the practical work; Continuous process improvement; Reporting and managing of quality issues; Manufacturing documentation review; Generation and update of manufacturing and process supportive documentatio